Status:
UNKNOWN
F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
Lead Sponsor:
American College of Radiology - Image Metrix
Collaborating Sponsors:
World Molecular Imaging Society
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient is \< 18 years old at the time of the drug administration
- Patient is pregnant or nursing;
- testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
- obtaining surgical history (e.g., tubal ligation or hysterectomy)
- confirming the subject is post menopausal, with a minimum 1 year without menses
- Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- Patient has known bone metastases
- Patient has previously received \[18F\]NaF in the last thirty days
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00882609
Start Date
January 1 2009
End Date
June 1 2013
Last Update
November 29 2012
Active Locations (19)
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1
Scottsdale Medical Imaging
Scottsdale, Arizona, United States, 85252
2
Silicon Valley Imaging
Freemont, California, United States, 94538
3
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
4
VA West Los Angles Medical Center
Los Angeles, California, United States, 90073