LUNG IMAGE DATABASE RESOURCE FOR IMAGING RESEARCH

Release Date:  April 10, 2000

RFA:  CA-01-001
 
National Cancer Institute
 
Letter of Intent Receipt Date:  June 9, 2000
Application Receipt Date:       July 14, 2000

PURPOSE 

The National Cancer Institute (NCI) invites applications from investigators 
who are interested in joining a consortium of institutions to develop the 
necessary consensus and standards for an image database resource and to 
construct a database of spiral computed tomography (CT) lung images. There is 
considerable interest in using spiral CT lung scanning for lung cancer 
screening for patients at high risk. Early detection and intervention may 
significantly reduce lung cancer mortality rates.  The use of image processing 
methods may be an important adjunct to facilitate spiral CT lung cancer 
screening.  Investigators developing image-processing algorithms need 
standardized databases with which to work.  The generation of standardized 
databases requires the development of consensus on many issues related to 
database design, accessibility, metrics and statistical methods for evaluating 
image-processing algorithms.  NCI therefore plans to establish a consortium of 
institutions, called the Lung Image Database Consortium (LIDC), to develop 
such consensus and the necessary database. 

HEALTHY PEOPLE 2010
 
The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas.  This Request for 
Applications (RFA), Lung Image Database Resource for Imaging Research, is 
related to the priority area of cancer.  Potential applicants may obtain a 
copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.  
 
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and 
non-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and Local governments, and eligible 
agencies of the Federal Government.  Applications may represent a single 
institution, or may involve two or more affiliated institutions or 
organizations if such affiliation is appropriate to the goals of this 
initiative.  NCI will form the Consortium from the selected awardees after 
the individual applications are reviewed.  Applicants to include more than 
one institution should consult NCI program staff at an early stage of the 
application preparation.  Minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators. 
MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Details of the responsibilities, relationships and governance of 
the study to be funded under cooperative agreement(s) are discussed later in 
this document under the section "Terms and Conditions of Award." 
 
The total project period for applications submitted in response to this RFA 
may not exceed 5 years.  The earliest anticipated award date is April 1, 
2001.    

Although this program is provided for in the financial plans of the NCI, 
awards pursuant to this RFA are contingent upon the availability of funds for 
this purpose. 
 
This RFA is a one-time solicitation.  

FUNDS AVAILABLE

The NCI intends to commit approximately $7 million total costs to the support 
of this initiative over 5 years.  The NCI intends to commit approximately 
$1.3 million in FY 01 to fund approximately 5 grants in response to this RFA.  
An applicant may request a project period of up to 5 years and a budget for 
direct costs of up to $200,000 per year, excluding Facility and 
Administrative costs on consortium arrangement.  Because the nature and scope 
of the research proposed might vary, it is anticipated that the size of each 
award will also vary.  Although the financial plans of the NCI provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications. At this time, it is not known if competing renewal applications 
will be accepted and/or if this RFA will be reissued.
 
RESEARCH OBJECTIVES
 
Background 

Preliminary clinical studies show that spiral CT scanning of the lungs can 
improve early detection of lung cancer in high-risk individuals.  However, 
more clinical data are needed before public health recommendations can be made 
for population-based screening. Image processing algorithms have the potential 
to assist in lesion (e.g., nodule) detection on spiral CT studies, and to 
assess the stability or change in size of lesions on serial CT studies.  The 
use of such computer-assisted diagnosis (CAD) image processing algorithms 
could significantly enhance the sensitivity and specificity of spiral CT lung 
screening, as well as lower costs by reducing the physician time needed for 
interpretation. 

Electronic image detectors such as those used in contemporary spiral CT 
scanners acquire more information than can be displayed at any one time, using 
standard display methods. Therefore, research on image processing methods is 
essential to fully exploit the information that has been acquired.  
Furthermore, ability to extract quantitative information from images is 
increasingly important and requires image processing.  Investigators working 
on image processing frequently do not have access to or the resources 
necessary to create the large databases of images necessary to develop and 
test their work.  In addition, the comparison and evaluation of image 
processing techniques against each other require common data sets and 
standardized methods for evaluation.  The need for medical image databases as 
research resources for medical image processing has often been identified as a 
priority at various NIH workshops [e.g., the NCI Lung Imaging Workshop and 
related Technology Transfer of January 1997, Image Processing Workshop of 
October 1998, and the NIH Biomedical Imaging Symposium of June 1999].  
Previous efforts to create image databases and make them widely available have 
met with limited success partly due to lack of consensus on critical issues. 

An example of the establishment of a successful image database as an 
international resource is the National Library of Medicine (NLM) Visible Human 
Project (VHP) initiated in 1989. This project was partly supported by the 
National Science Foundation (NSF).   VHP has proven to be far more useful than 
imagined at its inception.  It created a resource of CT and MRI images of male 
and female human cadavers, along with photographs of the corresponding cadaver 
sections.  This resource is continually used around the world for research and 
educational purposes.    NLM is currently supporting work to develop 
generalizable algorithms for segmentation and alignment using the VHP.  
Another example of an image database resource in development is the NIH 
collaborative effort called the Human Brain Project (HBP), begun in 1993, that 
seeks to create common tools to facilitate research on neuroinformatics. This 
project was also partly supported by NSF.  Some of these tools are image-
processing algorithms for neuroimaging such as brain CT, PET and MRI studies. 
The solutions that the VHP develops for normal anatomy, and that the HBP 
develops for brain imaging, will not necessarily transfer directly to other 
organ systems, but NCI will encourage exchange of information among the 
investigators supported by this initiative (LIDC), the VHP and the HBP. 

Computer-assisted diagnosis is a general term used for a variety of artificial 
intelligence techniques applied to medical images.  CAD methods are being 
rapidly developed at several academic and industry sites, particularly for 
large-scale breast, lung, and colon cancer screening studies. Imaging for lung 
cancer screening is a good physical and clinical model for the development of 
image processing and CAD methods, related image database resources, and the 
development of common metrics and statistical methods for evaluation.  
Automatic target recognition algorithms are one example of CAD.  For large-
scale screening applications, automatic target recognition is an important 
method for: (a) improving the sensitivity of cancer detection, (b) reducing 
observer variation in image interpretation, (c) increasing the efficiency of 
reading large image arrays, (d) improving efficiency of screening by 
identifying normal images, and  (e) facilitating remote reading by experts.  
Image processing tools are also being developed for temporal analysis of 
serial images, with the aim of detecting early subtle changes that might not 
be obvious to the reading physician. In addition, CAD techniques can improve 
the specificity of cancer detection by assigning a quantitative estimate of 
the probability that a detected lesion is benign or malignant. Another 
promising application of CAD is predicting which cases are most suitable for a 
particular treatment option. These types of CAD require consensus on such 
issues as the development of reference standards (electronic ground truth), 
software modules for registration of serial images and related image 
segmentation.  

Multimodality imaging (X-ray CT, MRI or PET/SPECT) will also be important for 
diagnostic image interpretation.  Therefore, development and implementation of 
multimodality image registration software is desirable. Finally X-ray CT image 
reconstruction methods may also influence the performance of CAD methods and 
hence the collection of raw image data needs to be considered in the design of 
an image database that is intended to be a general resource.

Objectives and Scope    
 
Introduction 

The intent of this initiative is to support a consortium of institutions to 
develop consensus guidelines for a spiral CT lung image resource, and to 
construct a database of spiral CT lung images.  The investigators funded 
under this initiative will create a set of guidelines and metrics for 
database use and develop a database as a test-bed and showcase for those 
methods.  The database created by this consortium will be available to all 
researchers and users through the Internet, and will have wide utility as a 
research, teaching and training resource.  

Specific goals of the RFA:

(1) Create a consortium (LIDC) to develop consensus guidelines for: (a) 
preparation and submission of lung CT cases that are representative of 
clinical practice, (b) reference standards (“ground truth”) for spatial 
determination of imaged lesions(s) electronically in 3 dimensions (3D) (c) 
standards for histologic verification of image lesion(s), (d) common metrics 
and software for statistical validation of the performance of image 
processing methods; 

(2) Create an image database as a common research resource to the medical 
imaging community to: (a) permit early identification of promising software 
methods from the diverse pool of emerging tools, (b) stimulate the 
development of advanced image processing methods including temporal analysis, 
and image registration; 

(3) Allow Internet access to the database by the broad imaging research 
community to stimulate inter-disciplinary research collaboration among 
researchers in academia, government and industry. Internet access will be 
accomplished by using the resources of the NIH to develop and provide the 
necessary infrastructure, with image access using DICOM standards.

It is anticipated that approximately 5 individual academic sites will be 
supported. There is a critical need to have broad representation from the 
medical imaging community to promote the development of consensus and 
establishment of standards. To ensure a representative database is collected, 
the final criteria for selection of awardees will include a requirement for 
the inclusion of different awardees representing a minimum of three different 
institutions and images from at least two different spiral CT X-ray imaging 
devices (i.e., from 2 different manufacturers). The individual awardee 
institutions do not need to provide images from more than one CT scanner 
manufacturer.  In creating the Consortium as a whole, NCI staff will ensure 
that images from at least two different scanner manufacturers will be 
included.  The generation of image subsets of either CT raw data or 
multimodality images is an optional secondary goal and thus no specific 
requirements are posed.  The Consortium will determine, after it is formed, 
what datasets of raw data and multimodality images will be useful and are 
practical to obtain.  

SPECIAL REQUIREMENTS

In order to ensure maximum progress in the projects funded by this initiative 
and to realize the maximum benefit for the cancer research community and 
ultimately for the ongoing battle against cancer, several special activities 
will be required of the funded investigators. Grantees will be required to 
develop a plan for the timely release of data to the cancer research 
community.  The LIDC will be directed by a Steering Committee (see Section 3 
below) which must meet together on a regular basis.   

Applicants should state in their applications their commitment to 
participating in these group activities and their commitment to the public 
release of data.  

o   The Steering Committee will organize a public meeting in year 2, open to 
all interested researchers working on image processing algorithm development 
and evaluation, to seek feedback on the plans for the database generation and 
evaluation.  Attendance at this meeting should be budgeted for. 
 
o   Conference calls of the Steering Committee and NCI program staff will be 
organized on a monthly basis to manage this project.  Funds must be budgeted 
for these.

o   The funding available for this initiative is specifically not to be used 
to perform the spiral CT scans.  The applicants should address the source and 
funding for the lung CT images and the corroborative data that would be made 
available to the public database.  
	
The following terms and conditions will be incorporated into the award 
statement provided to the Principal Investigator(s) as well as the 
institutional official at the time of award.   

Terms and Conditions of Award

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH Grant 
Administration policy statements.  [Part 92 applies when state and local 
governments are eligible to apply as a "domestic organization."]

As stated above, the administrative and funding instrument used for this 
program is a cooperative agreement (U01), an "assistance" mechanism (rather 
than an "acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity. Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project 
as a whole, although specific tasks and activities will be carried out as a 
collaboration among the awardees with coordination and facilitation by NCI 
Program Staff.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for the project as a whole, 
including research design and conduct, data collection, data quality control, 
data analysis and interpretation and preparation of publications, as well as 
collaborations with other awardees.  An NCI Program Staff member will 
coordinate and facilitate interactions and collaborations among the awardees 
(see section 3 below).

The primary purpose of the initiative is the creation of consensus guidelines 
and a database available to medical researchers. Within these constraints, 
awardees will retain custody of, and primary rights to, the data developed 
under these awards, subject to Government right of access consistent with 
current DHHS, PHS, and NIH policies.  Awardees must commit to the timely 
release of the data to the cancer research community through a mechanism and 
procedures to be planned and implemented by the awardees and the NCI. 

Awardees will be required to accept and implement the common protocol and 
procedures approved by the Steering Committee (see Section 3 below).

2.  NCI Staff Responsibilities

NCI Program staff will work closely with individual consortium investigators 
to facilitate collaborations within the consortium and with other NCI-funded 
research groups to ensure that all investigators have access to the image 
database and other resources that may be necessary to successfully achieve 
their research goals.  The NCI Program Director responsible for the 
individual awards will assist in the coordination of activities that involve 
all of the awardees such as the planning meetings. 

NCI Program Director and Imaging Technology Development Branch Chief will 
participate in and facilitate the development of the strategies for making 
database access widely available within the consortium and to the imaging 
research community.  The NCI Program Director and Imaging Technology 
Development Branch Chief will be voting members of the Steering Committee but 
cannot serve as chair and will coordinate and facilitate the work of the 
Steering Committee (see Section 3 below).

3.  Collaborative Responsibilities

A Steering Committee will be the main governing board of the LIDC, and will be 
composed of the PI of each awarded grant, a second member from each awarded 
grant selected by the PI, and the NCI Program Director and Imaging Technology 
Development Branch Chief.  Each of these members will have one vote.  The 
chairperson, who will be someone other than an NCI staff member, will be 
selected by the Steering Committee.  

The Steering Committee will have primary responsibility for implementation of 
the overall goals of the Consortium, refining the scope of the original 
applications submitted so that the work of the Consortium as a whole is 
integrated, and organizing research tasks for each participating site where 
necessary.  The Steering Committee’s responsibilities will include efforts to 
reach consensus on the criteria to populate the image database, to monitor the 
accrual of cases, to monitor image quality control, to review ground truth and 
related pathological confirmation to ensure commonality of methods at each 
site, to determine whether raw data will be incorporated in the database, to 
decide what multi-modality images to include, to expand the database if 
improved CT imaging sensors become available, to reach a consensus on the 
metrics and statistical methods for software evaluation, and to ensure DICOM 
standards are followed for image transfer and all patient related information.

The Steering Committee will be responsible for determining the image format 
and the mode of transfer to NIH for Internet general access. The Steering 
Committee will continue to monitor the implementation of the data release plan 
for the life of the awards.  It will also be responsible for the collaboration 
with other NCI-supported clinical trials where applicable (e.g., the ACRIN 
Cooperative Group), for establishing procedures for access to image databases 
and for ensuring appropriate selection of imaging protocols.  It will also be 
encouraged to interact with professional societies such as Radiological 
Society of North America and American College of Radiology, with government 
agencies such as NSF, and other NIH cooperative groups generating image 
databases (e.g., Human Brain Project, Visible Human Project) to ensure 
community acceptance of standards proposed for evaluation of the image data 
bases.  The Steering Committee will facilitate the conduct of studies and 
reporting and publication of study results. Subcommittees will be established 
by the Steering Committee, as it deems appropriate; the NCI staff members will 
serve on subcommittees, as deemed appropriate by the Steering Committee.  

The Steering Committee will review database submissions, follow-up 
information on cases selected for inclusion in the database, protocol and 
DICOM compliance, results of audits, and regulatory requirements at the 
participating centers, and formally report the results of its reviews to the 
NCI in writing.  The format and time intervals of such reports will be 
decided by the Steering Committee. 

The Steering Committee will meet three times in year 1 and two times per year 
in subsequent years.  The Steering Committee will be responsible for the 
organization of a public meeting in year 2, open to all interested 
researchers working on image processing algorithm development and evaluation, 
lung cancer screening, image databases, or any related activity, to seek 
feedback on the plans for the database generation and evaluation.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award) between award recipients and the NCI may be brought 
to arbitration.  An arbitration panel will be composed of three members -- 
one selected by the LIDC Steering Committee (with the NCI members not voting) 
or by the individual awardee in the event of an individual disagreement, a 
second member selected by NCI, and a third member selected by the two prior 
selected members.  This special arbitration procedure in no way affects the 
awardee's right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS 
regulation at 45 CFR Part 16.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
It is the policy of the NIH that women and members of minority groups and 
their sub populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993.
 
All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, 
Volume 23, Number 11, March 18, 1994, available on the web at the following 
URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are clear and compelling scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
“NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects” that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html 

Investigators may also obtain copies of the policy from the program staff 
listed under INQUIRIES. 

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT 
 
Prospective applicants are asked to submit, by June 9, 2000, a letter of 
intent that includes a descriptive title of the proposed research, name, 
address, and telephone number of the Principal Investigator, identities of 
other key personnel and participating institutions, and number and title of 
the RFA in response to which the application may be submitted. 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of subsequent applications, the information allows NCI 
staff to estimate the potential review workload and plan the review. 
              
The Letter of Intent is to be sent to Dr. Barbara Croft  listed under 
INQUIRIES by the letter of intent receipt date listed.
 	
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  Applications kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301/435-0714, E-mail: grantsinfo@nih.gov.  For those 
applicants with Internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm

General guidelines and format. 

The format should follow the general guidelines for PHS 398.  The applicant 
may include a discussion of some or all of the following topics in the 
appropriate sections  a-d of the Research Plan.  These topics are offered by 
way of example only.

o   A review of the challenges posed by the research objectives of this RFA, 
and the institution’s preliminary experience, such as spiral CT imaging 
protocols for screening and diagnostic follow-up studies, radiation dose 
considerations, image reconstruction,  image quality control, system for 
collecting patient-related information, DICOM standards for image transfer, 
image archive and computer network resources, population and development of 
image data bases, optimization and evaluation of related algorithms. In 
addition, consider describing multi-modality imaging protocols, if 
implemented, and proposals for creating sub-sets of database images from 
these modalities, as an optional secondary goal for the LIDC. 

o   Level of institution’s commitment to maintain lung cancer screening 
programs and state-of-the-art CT imaging methods during the time of these 
awards.

o   Institutional IRB issues related to the collection of patient data and 
data analysis in the context of this project. The databases should contain 
demographic and clinical information relevant to the software validation 
process (e.g., risk factors), but not individual identification data.  
o   Challenges posed by image noise characteristics that may affect the 
performance of image processing methods,  and the feasibility of including 
sub-sets of raw data to explore alternative image reconstruction methods.

o   Methods for obtaining pathological confirmation of lung nodule(s) by 
biopsy or other means, anticipated sampling errors, means for obtaining 
spatial  ground truth (GT) and methods to validate image registration and 
temporal analysis methods.

o   Methods proposed to populate the image database in terms of: (a) the 
total number of patient cases, (b) means for selection of representative 
cancer, benign and normal cases, (c) methods for selection of subsets of 
cases with varying level of difficulty, (c) criteria for selection of cases 
for serial or multi-modality imaging, and (d) criteria for selection of sub-
sets of cases for training and or testing of image processing algorithms and 
means to avoid bias in case selection.

o   Means to allow data mining for sub-sets of cases depending on 
researchers’ needs and methods to achieve interoperability with databases 
developed by other NIH activities (such as VHP and HBP).


o   Approach to obtain consensus for the development of common performance 
metrics, such as measuring detection events or the accuracy of  image 
registration. Similarly, common statistical evaluation criteria for proposed 
image processing and CAD software may also be discussed.

o   An overall management plan for the Consortium.

Applicants should request travel funds to attend two meetings per year of the 
Steering Committee (three meetings in the first year).  In the first year, 
applicants should plan for 2 investigators, the principal investigator and an 
additional senior investigator, to attend 3 Steering Committee meetings.  In 
the subsequent years, applicants should plan for the PI and another 
investigator to attend 2 Steering Committee meetings per year.  The Steering 
Committee will organize a public meeting in year 2; attendance at this 
meeting should be budgeted for.  Funds must be budgeted for monthly 
conference calls of the Steering Committee.    

The funding available for this initiative is specifically not to be used to 
perform the spiral CT scans.  The applicants should address the source and 
funding for the lung CT images and the corroborative data that would be made 
available to the public database.  

The RFA label available in the PHS 398 (rev.4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title, LUNG IMAGE DATABASE RESOURCE 
FOR IMAGING RESEARCH, and number, CA-01-001, must be typed on line 2 of the 
face page of the application form and the YES box must be marked.
 
The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.
 
Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
(20817 for express service)
 
At the time of submission, two additional copies of the application must also 
be sent to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8239 
Rockville, MD 20850 (express courier)
Bethesda, MD 20892-8239

Applications must be received by July 14, 2000.  If an application is 
received after that date, it will be returned to the applicant without 
review.  The Center for Scientific Review  (CSR) will not accept any 
application in response to this announcement that is essentially the same as 
one currently pending initial review, unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such an application must follow the guidance in the PHS Form 398 application 
instructions for the preparation of revised applications, including an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institute.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 
consideration. 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities of the National Cancer 
Institute in accordance with the review criteria stated below.  As part of 
the initial merit review, all applications will receive a written critique 
and undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed, assigned a priority score, and receive a second 
level review by the National Cancer Advisory Board.

Review Criteria
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.
 
1.  Significance.  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of the database on the concepts or methods that drive 
this field?

2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
U01?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Does the investigator demonstrate a commitment to 
cooperation with the other funded investigators in the LIDC and with NCI 
program staff in the development of a plan to create the database and the 
evaluation methodology and to make the database and other results available 
to the research community in a timely manner?   

3.  Innovation.  Does the project employ concepts, approaches or methods that 
are recognized as state of the art and acceptable as reference methods?  Are 
the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?
 
4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?  Is there 
demonstrated experience in the generation of spiral CT databases for lung 
cancer screening, case selection criteria, groung truth determination, and 
pathological confirmation?  Does the investigator have experience with image 
processing methods, such as optimization, evaluation and image registration 
methods using spiral CT or multi-modality imaging?  Is there experience with 
CT image reconstruction methods?  Is there evidence of knowledge of metrics 
and statistical criteria for evaluation of imaging processing algorithms, 
including temporal analysis methods?

5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success? Is there evidence of 
institutional support for lung cancer screening programs?  Is there access to 
state-of-the-art imaging sensors, namely spiral CT?  Is the organization 
experienced in CT quality control and DICOM standards for image transfer and 
patient information documentation?  What is the extent and design of the 
applicants’ existing image databases and corroborative data?  What is the 
commitment and ability to accrue more cases as needed? Are human subjects 
issues which would interfere with the creation of a database addressed?
 
The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders 
and minorities and their subgroups as appropriate for the scientific goals of 
the research and plans for the recruitment and retention of subjects; the 
adequacy of plans for including children as appropriate for the scientific 
goals of the research, or justification for exclusion; the provisions for the 
protection of human and animal subjects; and the safety of the research 
environment.

AWARD CRITERIA
 
Applications recommended by the National Cancer Advisory Board will be 
considered for award based upon (a) scientific and technical merit; (b) 
program balance, including in this instance, the desire to have at least 3 
different institutions and 2 different manufacturers' equipment represented 
in the Group; (c) geographic distribution; and (d) availability of funds. 

SCHEDULE
 
Letter of Intent Receipt:         June 9, 2000
Application Receipt Date:         July 14, 2000
Peer Review Date:                 October or November 2000
Review by NCAB Advisory Board:    February 2001
Earliest Anticipated Start Date:  April 1, 2001
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.
 
Direct inquiries regarding scientific responsiveness and programmatic issues 
to:
 
Barbara Y. Croft, Ph.D.
Biomedical Imaging Program
National Cancer Institute
6130 Executive Plaza, Room 800
Bethesda, MD  20892 
Telephone:  (301) 496-9531
Fax: (301) 480-5785
Email: bc129b@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8239
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to: 
 
Priscilla Grant
Grants Administration Branch 
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150 
Bethesda, MD  20892-7150
Telephone:  (301) 496-3160 
Fax: (301) 496-8601
Email: pg38h@nih.gov
 
AUTHORITY AND REGULATIONS
  
This program is described in the Catalog of Federal Domestic Assistance No. 
93.394, Cancer Detection and Diagnosis Research.  Awards are made under 
authorization of  Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a facility) 
in which regular or routine education, library, day care, health care or 
early childhood development services are provided to children.  This is 
consistent with the PHS mission to protect and advance the physical and 
mental health of the American people.  


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