The Academy of Molecular Imaging (AMI) has enrolled the first 10 patients in a new clinical trial investigating the use of fluorine-18 sodium fluoride (F-18 NaF) PET/CT to detect bony metastases.
The randomized, multicenter study will collect data from some 500 patients. It is designed to compare conventional planar technetium-99m methylene diphosphonate (Tc-99m MDP) bone imaging with F-18 NaF PET/CT in patients with breast, prostate, and non-small cell lung cancers. The protocol was developed in conjunction with the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services.
The AMI holds the investigational new drug application for the collaborative research effort between 13 clinical sites, the academy, and the molecular imaging industry.
PETNet Solutions, a subsidiary of Siemens Healthcare in Malvern, PA, furnished the initial F-18 NaF doses. GE Healthcare of Chalfont St. Giles, U.K., and IBA Molecular, North America, a division of radiopharmaceutical firm Ion Beam Applications (IBA) of Louvain-la-Neuve, Belgium, also will provide doses in the future.
The University of California, Los Angeles Medical Center; the VA Greater Los Angeles Healthcare System; and Scottsdale Medical Imaging in Arizona all have begun imaging patients.
Eight other sites are expected to participate upon investigational review board approval: Dartmouth-Hitchcock Medical Center, Stanford University Medical Center, Cedars-Sinai Medical Center, Washington University Medical Center, University of Utah Health Sciences Center, Memorial Sloan-Kettering Cancer Center, M. D. Anderson Cancer Center, and the University of Zurich.
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AMI, CancerSource launch consumer Web site, October 14, 2003
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