Molecular Imaging Program

Information for Investigators

Process for requesting resources

The Center for Quantitative Cancer Imaging (CQCI) at the Huntsman Cancer Institute includes the cyclotron/radiochemistry facility, PET/CT imaging infrastructure, oncology pre-clinical imaging infrastructure, and the tumor response assessment infrastructure. Certain aspects of this infrastructure is 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 PET imaging techniques it is critical that all proposed projects utilizing PET radiopharmaceuticals and the PET scanners be reviewed to assure that the Center for Quantitative Cancer Imaging can support the project. This is done by discussions with the Director of the CQCI John M Hoffman, MD in consultation with the Associate Director Jeff Yap, PhD. They will do the initial review of the proposed research and then in discussion with members of the center assess resources to do the proposed study.

All proposed grant or contract projects that propose the use of CQCI (PET/CT imaging including scanner utilization or radiopharmaceutical production) must first be discussed with Dr Hoffman. The project will be discussed as to 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. This would be in the form of the number of scans and required radiopharmaceuticals. After the initial meeting with Dr Hoffman the PI will be provided with costs for scanning and radiopharmaceutical production. The rates are based on calculations of time, effort, and other resources required for performing the study. In many instances there may be the need for additional resources and those need to be discussed with Dr Hoffman. 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 Programs (OSP). There must be approval of the Budget by Dr Hoffman prior to submission to OSP. If this process is not followed then there is no guarantee that the CQCI can support the proposed research. The Office of Sponsored Programs (OSP) will not submit a grant with PET/CT imaging if there is not approval by Dr Hoffman. 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 FDG-PET/CT imaging as a Patient Care Charge

Find below a schema for the use of CQCI Resources for a grant or contract. The schema provides a step by step process for development of a project and final approval to assure that resources will be available to support the research project if funded.

Development of “research idea” utilizing CQCI Resources

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Make an appointment with Dr Hoffman to discuss the proposed project. At that time the PI will be provided with basic scanning and radiopharmaceutical costs

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Prepare a preliminary budget and proposal (1-2 page document)

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The project will be assessed by Drs Hoffman and Yap and the Program for resource utilization and prioritized. Requested revisions will be provided to the PI if necessary

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If the project can be supported with available resources then the PI will be asked to prepare the final proposal and budget

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Prepare the final project and budget and present send to Dr Hoffman for review and final approval

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Dr Hoffman 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 assure that the project will be reviewed and the final budget approved in time for meeting grant submission deadlines.

Process for completing IRB application, PRMC application, and Human Use Subcommittee of the Radiation Safety Committee application

IRB
Each research project will require Institutional Review Board (IRB) approval. Please go to the following website to obtain information about completing the IRB submission for your project: http://irb.utah.edu/

PRMC
If your study involves cancer patients, you will be directed in ERICA to submit your project to the Protocol Review and Monitoring Committee (PRMC) of the Huntsman Cancer Institute for review and approval. You can find information on this process at the following weblink: http://research.utah.edu/integrity/human/ccic.php

To obtain information to complete the required radiation safety committee forms for PET imaging please go to the following weblinks for information regarding the process of obtaining approval for use of radioactive compounds.

http://www.rso.utah.edu/

http://www.osp.utah.edu/HANDBOOK/8-5.html

Human Use Subcommittee of the Radiation Safety Committee

The form titled “Protocol Radiation Use Review Sheet: found at the end of this document, 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 area available on request to Dr Hoffman.

All investigators using radiopharmaceuticals should be knowledgeable about the rules and regulations governing the use of these agents in human research subjects. The following websites provide this valuable information.

Radioactive Drug Research Committee

Radioactive Drug Research Committee (RDRC) Program, the U.S. Food and Drug Administration. 

Code of Federal Regulations, Title 21, Volume 5, 21CFR361.1, the U.S. Food and Drug Administration Website, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1 Revised

Investigational New Drug Process

Investigational New Drug (IND) process, the U.S. Food and Drug Administration Website, http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

Code of Federal Regulations, Title 21, Volume 5, CFR312.23, the U.S. Food and Drug Administration Website,
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23

Guidance for Industry: Medical Imaging Drugs
Guidance for industry: developing medical imaging drug and biological products. Part 1. Conducting Safety Assessments. U.S. Food and Drug Administration. Website, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078930

Guidance for industry: developing medical imaging drug and biological products. Part 2. Clinical Indications, U.S. Food and Drug Administration Website, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071603.pdf

Guidance for industry: developing medical imaging drug and biological products. Part 3. Design, Analysis, and Interpretation of Clinical Studies. U.S. Food and Drug Administration Website, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071604.pdf

Code of Federal Regulations, Title 21, Volume 5, CFR312.23, the U.S. Food and Drug Administration Website, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23

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. Please complete the review sheet available at the link below.

PROTOCOL RADIATION USE REVIEW SHEET