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Last Updated: 09/13/17

FLT Documentation Page

Component Documents for an IND for 3'-deoxy-3'-[F-18]fluorothymidine ([18F]FLT)

These documents include a full set of manufacturing and QC documents and an Investigator Drug Brochure, all of which have been accepted by the FDA as part of the NCI IND. The synthetic method implemented in these documents was reported in an abstract by Blocher, A. et al., Procedure for Routine Synthesis of [18F] FLT in High Activities. J. Nucl. Med; 42 (5), 257P, 2001. An automated synthesis has been reported recently by the same group using the same precursor: Reischl, G., et al., Simplified, automated synthesis of 3'[18F]fluoro-3'-deoxy-thymidine ([18F]FLT) and simple method for metabolite analysis in plasma. Radiochim Acta, 2006. 94: p. 447-451. Investigators at each site can implement the synthesis and testing in their radiochemistry laboratory. There is a CMC template that may need to be modified to match the local procedures (e.g. specific brands of equipment). Investigators can then write and file their own IND with the FDA by modifying the CMC section to fit local conditions and adding the Investigator's proposed Clinical protocol, and NCI will provide a letter to cross-reference the NCI IND file at FDA for pharmacology, toxicology, dosimetry, and previous human experience. You may wish to consult these FLT Frequently Asked Questions before going forward. Documents in this section includes;

For additional information, contact:

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