F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
Bone Tumor
Breast Cancer
Lung Cancer
Prostate Cancer
18 Years and older, Male and Female
Summary
The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT
scanning to that of conventional bone scanning for detecting cancer that has spread to
the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride
PET/CT will lead to improved treatment and patient outcomes.
Objectives
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.
Eligibility
- Patient is = 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
- Patient or patient's legally acceptable representative cognitively provides written informed consent
- Patients without known bone metastases who are newly diagnosed with = stage 3 breast cancer, = stage 3 lung cancer, or = stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer
- Patient is scheduled to undergo a conventional bone scan
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (about one hour)
- Patient may have had a prior PET or PET/CT scan for staging/restaging.
Treatment Sites in Georgia
1326 Eisenhower Dr
Savannah, GA 31406
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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