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;

• The [18F] FLT Investigator's Brochure as an Adobe PDF document or a Microsoft Word document
• The [18F] FLT Production Documents are presented in Adobe Acrobat and Microsoft Word formats, either in executable or ZIP format, to be maximally compatible with the computer system being downloaded into. The files are large in any format and should be downloaded with a fast Internet link:
  • Adobe PDF Generic Documentation for FLT as an Executable or as a compressed Zip file
  • Microsoft Word Generic Documentation for FLT as an Executable or as a compressed Zip file
• Updated specifications for [18F] FLT, for sites wishing to manufacture IND PET agents under the NCI IND
• Comprehensive Adverse Events and Potential Risks List (CAEPR) for [18F] FLT

For additional information, contact:

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