[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]
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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.
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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