SNM unveils bridge for imaging biomarker use in clinical trials

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The Society of Nuclear Medicine (SNM) has created the Molecular Imaging Clinical Trials Network in response to the need for streamlined processes for using imaging biomarkers in clinical research and practice.

There is widespread agreement that the use of imaging biomarkers in the drug development process can reduce the complexity and cost of the regulatory process and speed the timelines to clinical use. SNM has designed a model for the use of imaging biomarkers in clinical trials that spans drug development, molecular imaging, radiolabeled probe development and manufacturing and regulatory issues to integrate the use of investigational imaging biomarkers into multicenter clinical trials, according to SNM President Robert W. Atcher, PhD.

The network is designed to provide centralized investigational new drugs (INDs) for biomarkers of interest to the pharmaceutical and imaging communities and coordinate standardized imaging protocols across qualified multicenter clinical trial sites. The network will also provide information on qualified radiopharmaceutical manufacturers to help design and develop clinical trials, Atcher said.

The network received approval for the first centralized IND in September for F-18 fluorothymidine (FLT)—an investigational PET imaging biomarker that has promise for demonstrating tumor proliferation as a surrogate marker of effectiveness in the development of novel cancer therapies. Active clinical trials utilizing FLT are expected to begin in 2009, according to SNM.

The society expects the network to be fully functional in the first quarter of 2009. Enrollment in the imaging registry is active now, and discussions have already begun with pharmaceutical developers interested in near-term clinical trials using F-18 FLT.