NOT-EB-22-006: Notice of Special Interest (NOSI): Technological Innovations for Advancing Clinical SPECT Imaging

Notice of Special Interest (NOSI): Technological Innovations for Advancing Clinical SPECT Imaging

Notice Number:

NOT-EB-22-006

Key Dates

Release Date:

March 22, 2022

First Available Due Date:

June 05, 2022

Expiration Date:

May 08, 2024

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required) ;

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) ;

PAR-20-084 - NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) ;

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed);

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed);

PA-21-151 - NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed);

PA-21-259 - PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed);

PA-21-260 - PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required);

PA-21-261 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required);

PA-21-262 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed);

PA-21-052 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31-Diversity);

PA-21-048 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32);

PA-21-050 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30);

PA-20-176 - Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required);

PA-20-190 - Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed);

PA-20-202 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required);

PA-20-203 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed);

PA-20-206 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required);

PA-20-205 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed);

PA-19-125 - Mentored Quantitative Research Development Award (Parent K25 - Independent Clinical Trial Required);

PA-19-124 - Mentored Quantitative Research Development Award (Parent K25 - Independent Clinical Trial Not Allowed);

PA-20-187 - NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required);

PA-20-188 - NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Not Allowed);

PAR-21-271 - Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed);

PAR-21-272 - Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Clinical Trial Required).

NOT-EB-21-005 - NIBIB Guidance for Support of Clinical Trial Applications

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of an area of special interest in developing nuclear medicine imaging technologies to achieve more cost-efficient clinical Single-Photon Emission Computerized Tomography (SPECT) applications.

Background

Over the past few decades there have been a number of advances in SPECT instrumentation, including SPECT/Computer Tomography (SPECT/CT) , collimators that have shown improved spatial resolution in small animal imagers (promising spatial resolution in the (tens of) micron range in clinical applications), and attenuation correction algorithms that have improved absolute quantitation methods. Because, the spatial resolution of SPECT is limited only by the camera performance, not by the characteristics of the radiotracer, it has the possibility to deliver sub-millimeter clinical resolution within the patient. Also, given the variety of single photon emitting radioisotopes, SPECT can simultaneously image more than just one physiologic function in humans. Finally, an advantage of SPECT imaging is its lower camera cost compared to Positron Emission Tomography (PET) cameras. As new imaging agents become available and established, it is anticipated that SPECT radiopharmaceutical costs would also decrease through increased demand.

Over the past decades nuclear cardiology has demonstrated that SPECT imaging provides a highly cost-effective method for delivering clinical tomographic imaging and diagnosis and has spurred the development of dedicated cardiac imaging cameras now made available by the leading manufacturers. FDA approval of new cardiac SPECT radiopharmaceuticals are distributed world-wide for use in patient-based studies and are used as a gold standard for evaluating new therapies and cardiac interventions in clinical trials. SPECT has the capability to deliver the same advantages for other organ systems and diseases; of particular interest is in brain imaging for dementia studies and neuroscience as well as alpha- and electron-emitting targeted cancer therapy, due to the recent interest of these fields in the community.

Current practices in clinical patient-based, non-cardiac nuclear medicine studies rely on image acquisitions that quantify tracer uptake as a Standard Uptake Value (SUV) . This logic is also applied to the methods used to measure proteinopathies in brain with the amyloid and tau imaging agents, and almost all amyloid and tau imaging studies report the data as SUV measures. The same is true for emerging next generation oncology imaging agents.

Although PET, using C-11 labeling, is the optimal method for evaluating new radiolabeled molecules, SPECT can play a role in making analogs of these molecules broadly and inexpensively available for clinical applications. That is, PET remains focused on imaging protocols that require its current superior temporal resolution and sensitivity (i.e., imaging biomarkers having a low target density), and SPECT could contribute to procedures where delayed “hot spot” imaging (SUV-based quantitation) is used for a diagnosis or therapy efficacy evaluations. This would lead to reducing the cost of clinical trials and hospital-based imaging.

NIBIB Statement of Interest and Research Objectives

To decrease the cost of clinical trials and hospital patient diagnostics and new therapies, NIBIB is interested in supporting the development of new SPECT imaging technologies and SPECT analogues of the many available PET radiopharmaceuticals. Topics identified as high interest include, but are not limited to developing new imaging probes, and instrumentation, such as:

SPECT analogues for the newly discovered ligands, .e.g., beta-amyloid and tau PET tracers, as well as neuroreceptors, cancer-related physiologies, inflammation, and infectious agents;
new ligands with Tc-99m, In-111, I-123, or Cu-67 and other single-photon-emitting radioisotopes;
paired radiopharmaceuticals and applicable acquisition parameters which would allow multiple biological functions to be simultaneously evaluated and quantified during a single imaging session (e.g., perfusion and neuroreceptor uptake or glomerular filtration and tubular secretion).

SPECT cameras adapted to improve the imaging performance of electron and alpha emitting radiotherapeutic agents to directly measure the therapeutic agent’s tissue uptakes;
new detectors with improved measurement of the position, energy, and angle of incidence of photon interactions;
innovative collimation to improve SPECT camera image resolution;
nonconventional SPECT camera designs supporting static camera acquisition of tomographic images;
SPECT methods that enhances the simultaneous acquisition and independent analysis of multiple isotopes each with different gamma emissions.

Application and Submission Information

This notice applies to due dates on or after June 5, 2022 and subsequent receipt dates through May 8, 2024.

Applications in response to this Notice must be submitted through one of the following opportunity announcements (FOAs) (or subsequently reissued equivalents).

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required) ;

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) ;

PAR-20-084 - NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) ;

PA-20-195 -NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed);

PA-20-200 -NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed);