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IND Regulatory & Manufacturing Resources

Space-Filling [18F]Fluorodeoxyglucose Chemical Structure Model

[18F]Fluorodeoxyglucose

 

The Cancer Imaging Program has been creating Investigational New Drug Applications (IND) for imaging agents in order to engage in multi-center clinical trials of these materials. A subset of the documents filed is being made available to the research community to implement routine synthesis of tracers at their own facilities and to assist investigators with the filing of their own INDs.

Documents for several tracers are currently available: [18F]-sodium fluoride, [18F] fluorothymidine (FLT), [18F] FMISO (1H-1-(3-[18F]-fluoro-2-hydroxy-Propyl)-2-nitro-imidazole), [18F] FES (16-α-[18F] fluoroestradiol), [89Zr]-panitumumab, and [18F] DCFBC (N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine).

PET drug information from the U.S. Food and Drug Administration (FDA) can be found here: FDA PET Page

Agents with New Drug Application (NDA) held by NCI/CIP

Agents with Investigational New Drug (IND) Application held by NCI/CIP

Manufacturing IND PET agents under the NCI IND

For investigators who wish to manufacture IND PET agents at their own institutions under the NCI IND for a NCI-sponsored trial:

  • Please refer to the Frequently Asked Questions document, (v1.3 updated 2-1-2016, in Adobe PDF format).
  • A completed CIP Radiotracer Manufacturing Qualification sample application courtesy of the University of Wisconsin-Madison.

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:

Approved Sites
Site Name[18F]FLT[18F]FES[18F]FMISO
The University of Michigan Medical CenterX  
University of Alabama BirminghamX  
University of PennsylvaniaXX 
University of Wisconsin - MadisonXX 
University of Washington X 
Washington University (St. Louis)XX 
Brigham and Women'sX X
VanderbiltXX 
MayoX  
Yale  X
Southwestern Medical CenterX  
Midwest Medical Isotopes LLCX  
University of UtahX  
University of North CarolinaX  
University of Southern CaliforniaX  
Massachusetts General Hospital X 
University of Texas Southwestern Medical Center X 
Memorial Sloan Kettering Cancer Center X 

For additional information, contact

Ismahan Ugas, B.A.
Sr. IND Manager
Email: ugasi@mail.nih.gov
Phone: 240-276-6020

  • Updated:

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