F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

Not Recruiting

Trial ID: NCT00882609


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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


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

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