The Academy of Molecular Imaging (AMI) has begun a randomized, multi-center trial investigating the use of 18F-sodium fluoride PET/CT (18F-NaF) to detect bony metastases and reported that it has enrolled its first 10 patients.
The study compares conventional planar 99mTc-MDP bone imaging with 18F-NaF PET/CT in patients with breast, prostate and non-small cell lung cancers. The protocol was developed in conjunction with the FDA and Centers for Medicare & Medicaid Services (CMS), and calls for data on more than 500 patients. The University of California-Los Angeles Medical Center, the VA Greater Los Angeles Healthcare Systems and Scottsdale Medical Imaging in Scottsdale, Ariz., have all begun imaging patients.
“This exciting development is the culmination of many months work and an extraordinary level of collaboration,” said Johannes Czernin, MD, director of the nuclear medicine clinic and a professor of molecular and medical pharmacology at UCLA’s David Geffen School of Medicine and the principal investigator for the study. “Although AMI is the IND (Investigational New Drug application) holder, this important research is a result of cooperative efforts between 13 clinical sites, AMI and the molecular imaging industry. Siemens Healthcare/PETNET Solutions furnished these initial 18F-NaF doses and GE Healthcare and Ion Beam Applications (IBA) Molecular will also provide doses in the future.”
Cancer patients undergo more than 2 million planar 99mTc-MDP scans each year to determine whether the disease has metastasized to their bones. 18F-NaF PET/CT bone scanning may have advantages over this conventional method because it is able to find smaller metastases and differentiate more accurately between cancerous and non-cancerous conditions, according to the AMI.
“Cancer patients may receive better and timelier treatment if we are able to improve our ability to detect the spread of their disease earlier and more accurately,” said R. Edward Coleman, MD, professor of radiology, vice-chairman of the department of radiology and director of the division of nuclear medicine at Duke University School of Medicine in Durham, N.C.--which along with St. Louis University Hospital expects to begin enrolling participants soon. “This clinical trial is an example of the PET imaging community’s commitment to improve treatment and patient outcomes using scientifically rigorous research methods and analyses.”
Eight other sites are expected to participate on institutional review board approval, AMI said:
- 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,
- MD Anderson Cancer Center and the
- University of Zurich.
The American College of Radiology (ACR) said that its Image Metrix will provide data and image storage infrastructure for the study.