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 SPECT applications.

Background

Over the past few decades there have been a number of advances in SPECT instrumentation, including SPECT/CT, collimators that have shown improved spatial resolution in small animal imagers (promising spatial resolution in the 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 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. Recent 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, due to the recent interest of this field 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) 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.

Research Objectives

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 superior temporal resolution and sensitivity (e.g., 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

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

• new detectors with improved measurement of the position, energy, and angle of incidence of photon interactions (with acceptable detection sensitivity);
• innovative collimation to improve SPECT camera image resolution;
• nonconventional SPECT camera designs supporting static camera acquisition of tomographic images;
• development of 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;
• developing new ligands with Tc-99m, In-111, I-123, or Cu-67 and other single-photon-emitting radioisotopes.
• adapting SPECT cameras to improve the imaging performance of electron and alpha emitting radiotherapeutic agents to directly measure the therapeutic agent’s tissue uptakes.

Application and Submission Information

Applications in response to this Notice must be submitted through one of the NIH Parent Announcement PA-19-056 or NIBIB Parent Announcement PA-18-418. All instructions in the SF424 (R&R) Application Guide and PA-19-056 (or PA-18-418) must be followed, with the following additions:

Applications to PA-18-418 may propose early stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern.

For funding consideration under this initiative, applicants must include NOT-EB-19-022 in the Agency Routing Identifier Field (Box 4B) on the SF424 R&R Form. Applications without this information in Box 4B will not be considered for this initiative.

Applications nonresponsive to the terms of this Notice will be not be considered for this initiative.

Applicants planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NIBIB Program Officer listed on this NOSI well in advance of the grant receipt date.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.