Centralized Radiopharmaceutical INDs

Centralized Radiopharmaceutical INDsDespite general agreement that molecular imaging facilitates drug development, it has been historically difficult for the pharmaceutical community to effectively use molecular imaging agents in their multicenter clinical trials. This is due to a number of factors including lack of standardized clinical protocols for molecular imaging agents, lack of trained and certified imaging sites and lack of centralized, easy to cross-reference INDs for molecular imaging agents. One of the goals of the SNMMI Clinical Trials Network (CTN) is to facilitate community access to investigational molecular imaging radiopharmaceuticals. To accomplish this, the following strategies have been identified:  

  • Creation, approval, and maintenance of centralized INDs available to all CTN partners
  • Work to ensure proper Chemistry, Manufacturing, and Controls (CMC) documentation suitable for FDA-acceptance for multicenter-produced molecular imaging radiopharmaceuticals under an SNMMI/CTN-held IND
  • Work with radiopharmaceutical developers to incorporate their proprietary agents into clinical trials
Identified Need for Centralized IND for FLT

F-18 FLT is one example of an under-utilized radiopharmaceutical. At the Institute of Medicine (IOM) meeting in Washington, DC, on October 7, 2007, drugs and biologics developers of investigational therapeutics (Pfizer, Amgen, and Genentech) met with Dr. Janet Woodcock of the FDA and representatives from the National Cancer Institute. The developers explained that F-18 FLT, an investigational PET imaging radiopharmaceutical, has apparent promise as an imaging biomarker for demonstration of tumor proliferation.

Centralized FLT IND Approved

The review process subsequently resulted in the SNMMI/CTN receiving approval for the first centralized IND for F-18 FLT on October 1, 2008. This IND is fully-documented and addresses - and resolves - current barriers for cross-reference implementation in multicenter studies, incorporating:

  • Multiple, established F-18 FLT imaging centers & sub-investigators
  • Single, standardized PET-FLT imaging protocol to enable multisite harmonization
  • Standardized CRFs for Safety and Efficacy
  • Complete CMC & PharmTox documentation for all participating clinical sites for all F-18 FLT production

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