[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25400]


[[Page Unknown]]

[Federal Register: October 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

 

National Cancer Institute; Opportunity for a Cooperative Research 
Agreement (CRADA) for the Clinical Evaluation of Magnetic Resonance 
Imaging in Breast Cancer

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI) seeks major pharmaceutical 
companies that can effectively pursue the joint research, development, 
evaluation and commercialization of imaging drugs to be used for 
magnetic resonance imaging (MRI) in breast cancer. NCI will enter into 
CRADA negotiations with the sponsor(s) of the selected proposal(s).

ADDRESSES: Questions about this opportunity may be addressed to Mr. 
Eric Hale, Office of Technology Development, National Cancer Institute, 
Building 31, Room 4A34, 9000 Rockville Pike, Bethesda, Maryland 20892, 
(301) 496-0477.

DATES: Proposals must be received by January 1, 1995.

SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development 
Agreement'' or ``CRADA'' means the anticipated joint agreement to be 
entered into by NCI pursuant to the Federal Technology Transfer Act of 
1986 and Executive Order 12591 of October 10, 1987 to collaborate on 
the specific research project described below.
    Recent studies reported at the Diagnostic Imaging Research Branch, 
Radiation Research Program (DIRB/RRP) workshop indicated that breast 
MRI is more sensitive than conventional x-ray mammography in the 
detection of early breast cancer. Over the last few years, MRI of the 
breast also has emerged as one of the most promising clinical tools for 
staging (i.e. definition of multifocal and multicentric lesions) of 
breast cancer. Contrast-enhanced MRI has been shown to be a promising 
adjunctive diagnostic tool in the following clinical situations: (1) 
Failure of conventional mammography and physical examination to provide 
diagnosis; (2) detection of small lesions; (3) detection of multifocal 
and multicentric breast cancer; (4) breast cancer staging; and (5) 
differentiation of dysplasia and scarring versus cancer. While the 
sensitivity of breast MRI appears promising, the specificity of this 
technique has been reported to be low. However, the recent development 
of specialized coils and other equipment for MRI-guided biopsy is 
expected to have an important impact on tissue characterization of the 
MRI-detected lesions.
    DIRB/RRP convened a meeting of the NCI Advisory Group consisting of 
leading members of the international academic community and industry in 
order to discuss the possibility and feasibility of clinical trials in 
breast MRI at this time and to formulate specific clinical questions 
that can be answered by such studies. Current results support the 
hypothesis that MRI (combined with image-guided biopsy) can improve 
early detection and accurate staging of breast cancer. A number of 
important clinical issues will be addressed by the clinical trials in 
breast MRI anticipated under the CRADA(s), including:

    1. Definition of clinical indications for breast MRI studies and 
for MRI guided breast biopsy;
    2. Definition of clinical indications for breast MRI versus 
conventional x-ray mammography and other technologies;
    3. Study of the sensitivity and specificity of breast MRI in 
patients who will get pathological confirmation (eg., mastectomy, 
lumpectomy);
    4. Development of a patient follow-up database which would allow 
addressing of future clinical issues, such as whether or not breast 
MRI can eliminate unnecessary and inappropriate diagnostic and 
therapeutic interventions; and
    5. Study of the impact of MRI on the cost-effectiveness of 
breast cancer management (eg. through possible elimination of 
repeated lumpectomies, unnecessary radiation treatment, etc.).

    The expected duration of the CRADA is less than or equal to five 
(5) years.
    The role of the Diagnostic Imaging Research Branch (DIRB) of NCI 
under the CRADA(s) will include:

    1. The government initiating, coordinating, and sponsoring a 
multi-institutional cooperative group involving three to four 
institutions for a period of four years;
    2. The government supporting and coordinating the development of 
experimental study designs;
    3. The government supporting and coordinating statistical 
analysis on clinical data; and
    4. The government overseeing quality assurance for the clinical 
trials.

    The role of the successful pharmaceutical companies under the 
CRADA(s) will include:

    1. Providing imaging drugs and corresponding information to be 
used in the investigation of their potential use in MRI breast 
cancer diagnosis;

    2. Providing drug related analytical support that may be 
necessary during the course of the clinical trials;
    3. Providing access to INDs or NDAs that may need to be cross 
referenced;
    4. Providing assistance in clinical monitoring and data 
management;
    5. Providing collaboration in study design and data evaluation;
    6. Providing funds for assistance in supporting the clinical 
trials (eg. by contributing to the support of the NCI clinical study 
sites or supporting additional clinical sites); and
    7. Providing for the commercialization of resulting 
pharmaceutical products.

    Selection criteria for choosing the CRADA partners will include but 
not be limited to:

    1. Ability to provide investigational drugs at no cost to the 
government and necessary support according to an appropriate 
timetable to be outlined in the pharmaceutical company's proposal;
    2. The level of financial support the pharmaceutical company 
will supply for CRADA-related government activities;
    3. A willingness to cooperate with the NCI in the collection, 
evaluation, publication, and maintenance of data;
    4. An agreement to be bound by the DHHS rules involving human 
subjects;
    5. Experience in clinical drug development;
    6. Experience and ability to produce, package, market and 
distribute pharmaceutical products in the United States;
    7. Experience in the monitoring, evaluation and interpretation 
of the data from investigational clinical studies under an IND; and
    8. Provisions for equitable distribution of patent rights to any 
inventions. Generally, the rights of ownership are retained by the 
organization which is the employer of the inventor, with (1) an 
irrevocable, nonexclusive, royalty-free license to the government 
when a company employee is the sole inventor or (2) the grant of an 
option to negotiate an exclusive or a nonexclusive license to the 
company when a government employee is the sole inventor.

    Dated: October 6, 1994.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute, 
National Institutes of Health.
[FR Doc. 94-25400 Filed 10-13-94; 8:45 am]
BILLING CODE 4140-01-P