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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Sanjiv Sam Gambhir, MD, PhD
Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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