18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques
The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer,
prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine
bone scanning by their respective physicians. The specific stages of cancer required for
eligibility are described in the eligibility criteria.
Approximately eleven to fifteen qualified clinical centers will participate in the trial,
with target enrollment for each site set at roughly 40-50 patients per site.
The images of the patients will be transmitted to ACR Image Metrix, an imaging contract
research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded
core lab interpretations by 3 radiologists who have not been involved in the design of the
trial nor the clinical image interpretation. The data from the core lab readings will be
compared with the deliberations of a multidisciplinary panel of oncology experts who will be
blinded to the initial scan results and will determine the standard of evidence (truth) for
each patient. The analysis will be based on this comparison.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.
6 Months
No
Johannes Czernin, MD
Principal Investigator
World Molecular Imaging Society
United States: Food and Drug Administration
AMI-2008-01
NCT00882609
January 2009
June 2013
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Saint Louis University | St. Louis, Missouri 63104 |
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
UCLA | Los Angeles, California 90095 |
University of Utah School of Medicine | Salt Lake City, Utah 84132 |
University of Michigan Health System | Ann Arbor, Michigan |
Scottsdale Medical Imaging | Scottsdale, Arizona 85258 |
Silicon Valley Imaging | Freemont, California 94538 |
VA West Los Angles Medical Center | Los Angeles, California 90073 |
Cedar-Sinai Medical Center | Los Angeles, California 90048 |
SouthCoast Imaging Center | Savannah, Georgia 31406 |
John Cochran Veterans Administration | Saint Louis, Missouri 63106 |
New York Presbyterian Weill Cornell | New York, New York 10065 |