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

Useful links to other FDA imaging-related information.

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

• [18F] Sodium Fluoride

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

• [18F] Sodium Fluoride
• [18F] FLT
• [18F] FMISO
• [18F] FES
• [89Zr]-panitumumab
• [18F] DCFBC
• Hyperpolarized [13C] Pyruvate
• Ferumoxytol

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 list of sites currently approved to manufacture IND PET agents under the NCI IND.
• A completed CIP Radiotracer Manufacturing Qualification sample application courtesy of the University of Wisconsin-Madison.

For additional information, contact:

G. Craig Hill, Ph.D.
Email: hillgc@mail.nih.gov
Phone: 240-276-5913