The Center for Quantitative Cancer Imaging (CQCI) at Huntsman Cancer Institute (HCI) includes the cyclotron/radiochemistry facility, research PET/CT imaging infrastructure, oncology preclinical imaging infrastructure, and the tumor response assessment infrastructure. Certain aspects of this infrastructure are modest in size when compared to many major research universities. Due to the size of the infrastructure and its ability to support all university research interested in using research PET imaging techniques, it is critical that the CQCI co-directors, John M. Hoffman, MD, and Jeff Yap, PhD, review all proposed projects utilizing research PET radiopharmaceuticals and the research PET scanners to assure that the CQCI can support the project. Dr. Hoffman reviews studies involving human subjects and investigational radiopharmaceuticals. Dr. Yap reviews studies involving small animal imaging and tumor response assessments. The co-directors perform the initial review of the proposed research and then discuss the proposal with members of the center to assess necessary resources.
Investigators must discuss with Dr. Hoffman or Dr. Yap all proposed grant or contract projects that propose the use of CQCI (PET/CT imaging, including scanner utilization or radiopharmaceutical production). The investigator should prepare to discuss hypotheses, aims, feasibility, and intensity of resource utilization. After this initial discussion, the investigator will be asked to provide a preliminary proposal and anticipated use of the program resources, including the number of scans and required radiopharmaceuticals. After the initial meeting with Dr. Hoffman or Dr. Yap, the PI will be provided with costs for scanning and radiopharmaceutical production. Rates are based on calculations of time, effort, and other resources required for performing the study.
In many instances, the study may require additional resources. The investigator must discuss this first with Dr. Hoffman or Dr. Yap. A preliminary budget can then be prepared and submitted with the brief proposal. The project will then be reviewed and revised as required and be presented to the CQCI staff. Once this is done, the PI will be notified of any potential issues and ability to support the proposal. If there is an affirmative result, then the PI should prepare the grant/contract and final budget.
The final budget for the grant or contract should be prepared and provided for final approval prior to submission to the Office of Sponsored Projects (OSP). Dr. Hoffman or Dr. Yap must approve the budget prior to submission to OSP. If this process is not followed, there is no guarantee the CQCI can support the proposed research.
The OSP will not submit a grant with PET/CT imaging if there is not approval by Dr. Hoffman or Dr. Yap. This is to assure that the resources will be available to support the proposed project. This includes research projects as well as studies that utilize research FDG-PET/CT imaging as a Patient Care Charge.
Process for Requesting Resources
To request use of CQCI resources for a grant or contract, follow the step-by-step process below. This process ensures resources will be available to support the research project if funded.
- Develop the research idea that utilizes CQCI resources.
- Make an appointment with Dr. Hoffman or Dr. Yap to discuss the proposed project. At that time, the CQCI will provide the PI with basic scanning and radiopharmaceutical costs.
- Prepare a preliminary budget and proposal (1–2 page document).
- Submit the proposal to Dr. Hoffman and Dr. Yap, who will review the proposal for resource utilization and priority. The CQCI will request revisions if necessary.
- If the project can be supported with available resources, the PI will be asked to prepare the final proposal and budget.
- Prepare the final project and budget and present to Dr. Hoffman or Dr. Yap for review and final approval.
- Hoffman or Dr. Yap will notify OSP that the budget is reasonable and appropriate.
Please note that this process will take time and the PI should plan accordingly to ensure the project will be reviewed and the final budget approved in time for meeting grant submission deadlines.
Process for Completing Applications
Office of Sponsored Projects
Every researcher should make themselves aware of University research policies and compliance. Refer to the handbook for research and sponsored activity.
Each research project requires Institutional Review Board (IRB) approval. Please visit the IRB website to obtain information about completing the IRB submission for your project.
If your study involves cancer patients, you will be directed in ERICA to submit your project to the Protocol Review and Monitoring Committee (PRMC) at Huntsman Cancer Institute for review and approval.
Review the University of Utah’s Radiation Safety website for more information about the process of obtaining approval for use of radioactive compounds and to complete the required radiation safety committee forms for PET imaging.
Human Use Subcommittee of the Radiation Safety Committee
The Protocol Radiation Use Review Sheet, the complete protocol, imaging manual if available, and other relevant documents need to be submitted to Dr. Hoffman for review. The research PET and CT dosimetry calculations required for the study will be prepared based on the information provided
PET Agent Dosimetry
Dosimetry for several of the PET radiopharmaceuticals are available on request to Dr. Hoffman.
U.S. Food and Drug Administration Rules and Regulations
Radioactive Drug Research Committee
- Radioactive Drug Research Committee (RDRC) Program
- Code of Federal Regulations, Title 21, Volume 5, 21CFR361.1
Investigational New Drug Process
Guidance for Industry: Medical Imaging Drugs
- Part 1: Conducting Safety Assessments
- Part 2: Clinical Indications
- Part 3: Design, Analysis, and Interpretation of Clinical Studies
- Code of Federal Regulations, Title 21, Volume 5, CFR312.23
All new research studies utilizing ionizing radiation require completion of the Protocol Radiation Use Review Sheet. This should be completed by the principal investigator prior to submission of the study for review within the Center for Quantitative Cancer Imaging and at the Human Use Subcommittee of the Radiation Safety Committee.