Critical Milestone Achieved in NaF Clincial Trials: 500+ Patients Enrolled

The World Molecular Imaging Society (WMIS) announced today that over 500 patients are now enrolled in the Sodium Fluoride NaF clinical trial (18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques). The NaF clinical trial was launched in 2008 and patient enrollment began in 2009. WMIS is coordinating the NaF trials and through NOPRA is also managing the NaF registry.

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(PRWEB) February 12, 2013

The World Molecular Imaging Society (WMIS) announced today that over 500 patients are now enrolled in the Sodium Fluoride NaF clinical trial (18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques). The NaF clinical trial was launched in 2008 and patient enrollment began in 2009. WMIS is coordinating the NaF trials and through NOPRA is also managing the NaF registry.

“We are excited to have achieved this milestone. This information gathered from a large representative set of patients will enable us to demonstrate the efficacy and value of NaF. PET is at the center of powerful new emerging diagnostic technologies that are enabling better and early detection of various diseases. We are thankful to our partners PETNET, GE, and IBA who continue to collaborate with us on this critical study,” said Kim Pierce, Executive Director of WMIS.

Dr. Zaver Bhujwalla, President of WMIS, said “The scientific evidence acquired through NaF clinical trial would benefit patients and the medical community. As a society, we continue to play a significant and worthy role in the clinical PET segment. Our footprint in the PET segment is deep and profound.”

Dr. Juri Gelovani, past President of WMIS said “This is a significant achievement for WMIS and for all the partners involved in this clinical trial. What makes WMIS unique is its focus on enabling cutting edge innovation in the molecular imaging field as it supports and guides innovations from discovery to delivery.”

The PET imaging probe 18F-Sodium Fluoride (NaF) is being evaluated in the clinical trial. Sodium Fluoride NaF is a tracer that offers higher level of sensitivity for changes in bone. It can be used with PET to detect bone metastases.

Current Medicare policy covers NaF-18 PET for Medicare beneficiaries only under an approved coverage with evidence development (CED) study. The National Oncologic PET Registry (NOPR) sponsored by WMIS is the only qualifying clinical study for NaF-18 PET that will enable Medicare coverage.

The primary objective of the study is to compare diagnostic performance of 18F NaF PET/CT to conventional bone scanning for the detection of bone metastasis. The secondary objectives are: 1) Determine the number of equivocal tests from each modality (PET vs. conventional); 2) Determine the impact of each modality on patient management; and 3) Report the number of adverse events.

Nearly 2 million conventional bone scans are performed each year.

About WMIS
WMIS is an academic and professional society for Molecular Imaging. From leading projects such as PET awareness campaigns and registry management on the clinical side to developing powerful preclinical models and training programs, WMIS is active across the entire spectrum of Molecular Imaging. WMIS is the world's most innovative and leading society in molecular imaging and molecular medicine. With the rise of the molecular imaging industry and the associated research, WMIS is the only organization that is connecting all the dots in the industry and is working to bring all stakeholders together by Smashing the Silos and Leading Innovation Convergence in molecular medicine through imaging; both for practitioners and researchers, who are defining the future of molecular imaging, WMIS enhances the potential and applications of innovation. http://www.wmis.org


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