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Programs & Resources

IND Regulatory & Manufacturing Resources

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

For investigators who wish 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, (v1.2 updated 1-12-2016, in Adobe PDF format).
  • A list of sites currently approved to manufacture IND PET agents under the NCI IND can be found here.
  • A completed CIP Radiotracer Manufcaturing Qualifcation sample application can be found here courtesy of the University of Wisconsin-Madison.

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

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

For additional information, contact:

G. Craig Hill, Ph.D.
Phone: 240-276-5913