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Information for Investigators

Information for Investigators

The Molecular Imaging Program at Huntsman Cancer Institute provides investigators with the most advanced molecular imaging technologies, including radiopharmaceuticals and instrumentation, to enable the highest quality research.

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MOLECULAR IMAGING RESEARCH RESOURCES

If you are an investigator and would like more information on the Molecular Imaging Program, you may contact us or request access to the Molecular Imaging Program portal.

The portal contains information on the process for requesting Molecular Imaging Program resources and radiation dosimetry/exposure information for many different study types. The radiation dosimetry and exposure values require calculations and vary by the radiopharmaceutical and the type of CT to be done. Please contact John Hoffman, MD to discuss the study and he will work with you as the authorized user to make sure that radiation dosimetry/exposure tables and values are correct for your project and study.

Ian Wang
Research Associate -Molecular Imaging
Huntsman Cancer Institute
1950 Circle of Hope, Suite 6810
Salt Lake City, UT 84112
Tel: 801-587-4798
Fax: 801-587-4008
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

ORDER FORMS FOR CLINICAL TRIALS, RESEARCH PET/CT, OR PET SCANS

The following forms are used to order PET and PET/CT scans for research purposes:

UNIVERSITY RESEARCH RESOURCES

Process for completing IRB application, CCIC 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://www.research.utah.edu/irb/

CCIC
If your study involves cancer patients then you need to first submit your project to the
Clinical Cancer Investigations Committee (CCIC) of the Huntsman Cancer Institute for review and approval. You can find information on this process at the following weblink
http://www.research.utah.edu/integrity/human/ccic.html

The following is the weblink to the CCIC form that must be completed and submitted for review.
http://www.research.utah.edu/integrity/human/CCIC%20Cover%20Sheet
%20with%20MDG.doc

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 following form (RPR48A) will need to completed for a PET study. The investigator should complete the various parts of the form except for the items related to the radiopharmaceutical or radiation exposure/dosimetry section as that will be completed by Dr Hoffman as the authorized user.
http://www.rso.utah.edu/policies/rpr/48%20hus/48a%20rdrc.pdf

The following form (RPR48B) is to be completed for the CT portion of a PET/CT study. The investigator should complete the various parts of the form except for the items related to the CT scanner specifics or radiation exposure/dosimetry section as that will be completed by Dr Hoffman as the authorized user.
http://www.rso.utah.edu/policies/rpr/48%20hus/48b%20rdrc.pdf

Radioactive Drug Research Committee

Radioactive Drug Research Committee (RDRC) Program, the U.S. Food and Drug Administration.. Website, http://www.fda.gov/cder/regulatory/RDRC/
default.htm#RDRC

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, Revised April 1, 2003, Accessed September 3, 2007

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/cder/guidance/5742prt1.pdf

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/cder/guidance/5742prt2.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/cder/guidance/5742prt3.pdf

Code of Federal Regulations, Title 21, Volume 5, CFR312.23, the U.S. Food and Drug Administration Website, Revised April 1, 2003, Accessed September 3, 2007

 

 

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