The SNM has announced the formation of the Molecular Imaging Clinical Trials Network, a multi-institutional effort to establish scientifically sound, efficient ways to evaluate proposed clinical applications of biomarker imaging.
The network will provide centralized investigational new drugs (INDs) for biomarkers of interest to the pharmaceutical industry for new drug research and to molecular imaging researchers for diagnostic applications, according to SNM president Robert W. Atcher, Ph.D. It will also coordinate standardized imaging protocols and equipment calibration for multicenter clinical trials.
"The plan specifically includes the creation of a Biomarker Use Pathway, which will provide SNM-sponsored centralized INDs that pharmaceutical manufacturers can cross-reference for their multicenter trials," Atcher said in a release.
Early network efforts advanced in September with the FDA's approval of the first centralized IND application for F-18 fluorothymidine (FLT), a molecular imaging probe that measures cell proliferation, a potentially important measure for the response of cancer to therapy. A new set of F-18 FLT cancer imaging trials in humans will begin in 2009, according to the release.
Early human clinical trials of F-18 FLT produced mixed results for initial diagnosis, staging, and therapeutic response monitoring of brain, lung, prostate, breast, and ovarian cancers.
The network plans to assemble a registry of imaging centers to participate in future clinical trials. They will work together to adopt uniform equipment calibration methods and procedural protocols that permit valid multisite tests of MI probe performance.
"We're actively building the registry now for imaging centers interested in participating in the first round of clinical trials," Atcher said.
Program organizers plan to have the network ready to perform scientific investigation in the first quarter of 2009. A PET phantom has been developed to aid equipment calibration at imaging services participating in the trials, according to the SNM.
The network will help participating sites apply uniform standards of patient preparation and imaging for the trials. Participants will be trained during regional workshops, such as a two-day program planned for early February in Clearwater, FL.
"We couldn't be more excited about removing the bottlenecks that have existed for both drug developers and imagers," Atcher said in a release. "The FDA, pharmaceutical companies, and SNM community have all been extremely cooperative in designing the Molecular Imaging Clinical Trials Network because it is about building bridges and moving the field forward."
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