F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
Status unconfirmed · Phase 3
Conditions studied: Bone Metastases
In brief
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.
Key facts
- Study ID
- NCT00882609
- Run by
- American College of Radiology - Image Metrix
- People needed
- 550
- Starts
- 2009-01-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2012-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Scottsdale Medical Imaging — Scottsdale, Arizona, United States (enrolling)
- Peter MacCallum — Melbourne, Victoria, Australia (enrolling)
- PET-CT Linz - St. Vicent's Hospital — Linz, Linz, Austria (enrolling)
- Hospitais da Universidade de Coimbra — Coimbra, Portugal, Portugal (enrolling)
- VA West Los Angles Medical Center — Los Angeles, California, United States (enrolling)
- UCLA — Los Angeles, California, United States (enrolling)
- Stanford University Medical Center — Stanford, California, United States (enrolling)
- SouthCoast Imaging Center — Savannah, Georgia, United States (enrolling)
- University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
- Saint Luke's Hospital — Kansas City, Missouri, United States (enrolling)
- John Cochran Veterans Administration — St Louis, Missouri, United States (enrolling)
- Saint Louis University — St Louis, Missouri, United States (enrolling)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
- New York Presbyterian Weill Cornell — New York, New York, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Utah School of Medicine — Salt Lake City, Utah, United States (enrolling)
- Silicon Valley Imaging — Freemont, California, United States
- Cedar-Sinai Medical Center — Los Angeles, California, United States
- University Hospital Zurich — Zurich, Switzerland, Switzerland
Full record on ClinicalTrials.gov
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