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Last Updated: 05/06/21

Approved Manufacturing Sites for IND PET Agents under NCI INDs

For all NCI-sponsored trials involving an IND PET imaging agent, the NCI IND must be used for the trial. In addition to commercial vendors who have agreed to manufacture agents under the NCI IND, investigators can choose to make the IND PET agent at their own institutions after receiving approval from the Cancer Imaging Program in NCI. Please note that this option is meant only for sites experienced with manufacturing IND PET agents and involves an application and approval process. Please see the Frequently Asked Questions document for more information on this approach.

Once approval is obtained for a particular IND PET agent (e.g. [18F]FLT or [18F]FMISO), the approved site can manufacture that specific IND agent for any other NCI-sponsored trials, subject to periodic re-certification requirements. In other words, approvals are site and agent-specific rather than trial-specific. Below please find the table of currently approved sites and the IND PET agent that the site is approved for:

Site Name [18F]FLT [18F]FES [18F]FMISO
The University of Michigan Medical Center X
University of Alabama Birmingham X
University of Pennsylvania X X
University of Wisconsin - Madison X X
University of Washington X
Washington University (St. Louis) X X
Brigham and Women's X X
Vanderbilt X X
Mayo X
Yale X
Southwestern Medical Center X
Midwest Medical Isotopes LLC X
University of Utah X
University of North Carolina X
University of Southern California X
Massachusetts General Hospital X
University of Texas Southwestern Medical Center X
Memorial Sloan Kettering Cancer Center X