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.



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