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F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
Not Recruiting
Trial ID: NCT00882609
Purpose
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.
Official Title
18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
device: Bone Scan: F18-Fluoride PET/CT or TC-MDP
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061