The Academy of Molecular Imaging (AMI) has enrolled 185 patients in a multi-center imaging trial investigating the use of 18F-sodium fluoride PET/CT (18F-NaF) to detect bone metastases.
The study compares conventional planar 99mTc-MDP bone imaging with 18F-NaF PET/CT in a large number of patients with breast, prostate and non-small cell lung cancers. The protocol was developed in conjunction with the FDA and Centers for Medicare and Medicaid Services (CMS) using scientifically rigorous research methods, and will include data on more than five hundred patients, according to AMI. Currently, 14 of the 18 participating centers have enrolled patients.
The National Oncologic PET Registry (NOPR) plans to begin data collection on PET scanning using 18F-NaF. “Data acquired from this multi-center randomized trial will play a critical role in strengthening the case for CMS reimbursement and initiating the ultimate clinical adoption of 18F-NaF PET/CT bone scanning,” said Ed Coleman, MD,director, nuclear medicine, Duke University School of Medicine in Durham, N.C. “The NOPR data on NaF bone scanning will provide important data on the impact of the bone scan on intended patient management, and possibly correlate the intended management with the actual management by merging the NOPR database with the CMS claims database, but the NOPR results will not substitute for a well controlled prospective study such as being performed by the AMI,” Coleman added.
AMI said it is currently in discussions with several industry partners who are interested in contributing to this clinical trial.