[Federal Register Volume 60, Number 134 (Thursday, July 13, 1995)]
[Notices]
[Pages 36152-36153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17156]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


Warren Grant Magnuson Clinical Center: Opportunity for a 
Cooperative Research and Development Agreement (CRADA) for the 
Scientific and Commercial Development of High Resolution PET Scanner 
Using Scintillation Cameras

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Medicine Department in the Clinical Center at the 
Warren Grant Magnuson Clinical Center is seeking a collaborator with 
expertise in imaging equipment. The primary focus of this collaboration 
will be the development and commercialization of an imaging device that 
is capable of three distinct types of imaging at high resolution: 
Single photon planar imaging, single photon emission computed 
tomography (SPECT), and positron emission tomography (PET). An 
invention that has set the groundwork for this technology is claimed in 
U.S. Patent Applications 08/235,310, entitled ``Variable Axial Aperture 
Positron Emission Tomography Scanner'' (filed April 29, 1994) and (CIP) 
08/357,574 (filed December 15, 1994). These patents have been filed for 
the initial phase of foreign filing (PCT) designating all states. NCI 
seeks a collaborator that will apply the technology to develop imagers 
for human subjects and/or for high resolution PET imaging of small 
animals.
    Sponsors will be selected based on their ability to develop and 
commercialize the new imaging technology. NCI will enter into CRADA 
negotiations with the chosen sponsor with the intention of awarding a 
CRADA.
    The term of the CRADA(s) is anticipated to be three (3) to five (5) 
years.

ADDRESSES: Inquiries and proposals regarding this opportunity should be 
addressed to either Michelle Rhyu or Bill Cotreau (Tel # 301-496-0477, 
Fax# 301-402-2117), Office of Technology Development, National Cancer 
Institute, Building 31, Room 4A49, NIH, 9000 Rockville Pike, Bethesda, 
MD 20892.

DATES: Interested parties should notify this office in writing by 
September 11, 1995. Respondents will then be given an additional sixty 
(60) days for filing a formal proposal.

SUPPLEMENTARY INFORMATION: A Cooperative Research and Development 
Agreement (CRADA) is 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. Under the present proposal, 
the CRADA will focus on developing the following technology:
    An instrument has been devised that utilizes conventional 
scintillation cameras to support single photon planar imaging, single 
photon emission computed tomography (SPECT), and positron emission 
tomography (PET). These multiple capabilities rely on the device's 
ability to efficiently detect gamma rays at single photon energies 
(<200 keV) and higher positron annihilation energies (511keV) required 
for PET. This dual ability is conferred by pivoting the detectors in 
conventional scintillation devices, which are capable of only SPECT and 
planar imaging, thereby increasing the path length of the high energy 
positron in the detector and enabling its detection. The cameras may 
rotate about a fixed target, or stationary cameras may surround a 
rotating target. The invention makes PET scanning on small animals 
feasible, allowing the economical collection of test data. Moreover, 
the invention presents a promising approach to economically increasing 
the detection capability of conventional SPECT scanners for humans.
    Two broad advantages are provided by the present invention: (1) 
Resolution of PET is improved from 6mm to 2-3mm, making possible the 
resolution of organs in small animals. This expands the usefulness of 
small animals in research, for example in determining how test tracer 
molecules are incorporated into tumors, or how specific therapies 
affect tumor growth. The invention affords the advantage of using small 
animals, which are easier and less costly to maintain than larger 
animals. The ability to carry out PET analysis on smaller animals also 
circumvents the need to dissect the animal in order to assay an effect, 
greatly reducing the number of animals required for a study. (2) 
Applying this technology to human imagers, the invention provides a 
cost-effective way of improving diagnostic capabilities for 

[[Page 36153]]
a relatively modest expense. For hospitals that may be financially 
prohibited from operating a full scale PET imaging system (including 
onsite cyclotron and radiochemistry lab) the present invention could 
impart PET scanning capabilities to the lower cost SPECT instruments, 
reducing overall cost and promoting widespread PET use. The 
collaboration would likely focus on demonstration of concept with a 
prototype system, development of methods to further increase 
coincidence detection efficiency, e.g., use of 3D reconstruction, and 
development of efficient methods for performing transmission imaging 
and other required corrections.
    Background patent rights to this technology are available for 
licensing through the Office of Technology Transfer, NIH. Pertinent 
patent application claims may be obtained under a NIH Confidentiality 
Agreement for the Purpose of Reviewing Patent Application Claims. For 
this and further licensing information contact Mr. John Fahner-
Vihtelic, Office of Technology Transfer, National Institutes of Health, 
Suite 325, 6011 Executive Boulevard, Rockville, Maryland 20852, Tel 
(301) 496-7057, Fax (301)402-0220.

Party Contributions

    The role of the Warren Grant Magnuson Clinical Center includes the 
following:
    (1) Cooperate with Collaborator to create a prototype SPECT/PET 
scanning device following the above described specifications; advise 
Collaborator on how best to scale up the invention into a prototype 
device.
    (2) Evaluate prototypes produced by collaborator using small animal 
subjects.
    (3) Provide personnel and laboratory space for these studies.
    The role of the successful corporate sponsor(s) will include:
    (1) Build a prototype SPECT/PET scanning device.
    (2) Provide expertise in commercial scale up of imagers.
    (3) Provide funding for assistance in supporting the research.
    (4) Provide resources to bring product to market.

Selection Criteria

    Proposals submitted for consideration should fully address each of 
the following qualifications:
    (1) Expertise and experience in devising, producing and 
manufacturing imaging devices; specifically, sufficient expertise to 
collaborate on development of a SPECT/PET device.
    (2) Willingness to produce a scanner optimized for small animal 
studies and/or a scanner for use on human subjects.
    (3) Demonstrated ability to market invention to a broad client 
base.
    (4) Willingness to cost share in laboratory studies including the 
funding of personnel dedicated to completion of the CRADA research 
project.
    (5) Willingness to provide the Clinical Center with a prototype 
SPECT/PET device for future research.
    (6) Submission of an initial response to the NIH Model CRADA 
boilerplate provisions.
    (7) Provisions for equitable distribution of patent rights to any 
inventions generated in the performance of research under the CRADA. 
Generally, the rights of ownership are retained by the organization 
that 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 for an exclusive or a nonexclusive license to the 
Collaborator when a government employee is the sole inventor.


    Dated: May 7, 1995.
Steven M. Galen,
Technology Development Coordinator, Warren Grant Magnuson Clinical 
Center, National Institutes of Health.
[FR Doc. 95-17156 Filed 7-12-95; 8:45 am]
BILLING CODE 4140-01-P