NOVEL NON-IONIZING RADIATION TECHNOLOGIES FOR BREAST CANCER IMAGING NIH GUIDE, Volume 21, Number 9, March 6, 1992 PA NUMBER: PA-92-45 P.T. 34 Keywords: Medical/Diagnostic Imaging Cancer/Carcinogenesis INSTRUMENTS/INSTRUMENTATION/DEVICE Ultrasonic Technology National Cancer Institute PURPOSE The National Cancer Institute (NCI) through the Diagnostic Imaging Research Branch (DIRB) of the Radiation Research Program seeks grant applications to conduct multidisciplinary research in the area of novel non-X-ray technology development and evaluation for improved breast cancer imaging. This Program Announcement encompasses a full range of studies from basic technology and instrumentation development through pre-clinical and clinical evaluation. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Novel Non-Ionizing Radiation Technologies for Breast Cancer Imaging, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, public and private, nonprofit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This program will be supported by the individual research grant (R01) and the First Independent Research and Transition (FIRST) Award mechanisms. Awards will be administered in accordance with the Public Health Service Policy as described in the PHS Grant Policy Statement, DHHS Publication No. (OASH) 90-50,000 revised October 1, 1990. RESEARCH OBJECTIVES The goal of this Program Announcement is to stimulate development and validation of novel non-ionizing radiation technologies and imaging methodologies for the improved diagnosis and characterization of breast cancer. Background Current data indicate that conventional mammography is a mature imaging technology producing high-quality images in the majority of patients. Indeed, conventional mammography has been shown to be an accepted problem-solving and an effective screening tool in older women (age category over 50 years), resulting in a 30 percent mortality reduction in these patients. However, recent data indicate that novel technologies, such as conventional magnetic resonance imaging (MRI) and ultrasound, may provide important additional diagnostic information if the detected lesions need to be characterized (e.g., cystic vs. solid mass) and/or in younger women and patients with radiodense breast tissue. Further clinical studies are required to define the comparative role and analyze the cost-effectiveness of MRI and ultrasound in breast cancer diagnosis and characterization. Dynamic contrast-enhanced MRI has been shown to be a promising adjunctive diagnostic tool in the following clinical situations: (1) conventional mammography and physical examination fail to provide diagnosis; (2) the differentiation of dysplasia vs. cancer; (3) dense breast; and (4) small lesions. Advanced MRI and ultrasound technologies appear to have an important potential for quantitative characterization of tumor biology. Novel ultrasound technologies, such as high frequency systems, modern pulse echo/color flow, and 2D/3D imaging, may improve image quality and provide improved anatomic and physiologic information. Novel MR techniques, such as magnetization transfer approach, diffusion/perfusion imaging, magnetic resonance spectroscopy and electron spin resonance, will provide additional quantitative biochemical, biophysical, and physiologic parameters for breast cancer characterization in order to optimize treatment planning. Further, a number of novel imaging techniques (e.g., optical, microwave, thermal) are currently under development. Indeed, recent reports indicate that the ballistic optical imaging technique, while highly experimental at this stage, can detect structures in vitro as small as 200 microns. Further studies are required to advance this technology for in vivo use. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including not but limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (revised 9/91) is to be used in responding to this Program Announcement. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441. The Program Announcement number and title must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and five signed, exact photocopies in one package to the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications will be accepted on the standard receipt dates for new applications: October 1, February 1 and June 1. If the application submitted in response to this program announcement is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this announcement that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquires concerning the objectives and scope of this Program Announcement and inquiries about whether or not specific proposed research would be responsive are encouraged and are to be directed to: Faina Shtern, M.D. Chief, Diagnostic Imaging Research Branch Radiation Research Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9531 The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding fiscal matters to: Marian F. Focke Grants Administration Branch National Cancer Institute Executive Plaza South 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 46 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A. (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285), and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |