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

Trial ID or NCT#

NCT00882609

Status

not recruiting iconNOT RECRUITING

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

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
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Investigator(s)

Sandip Biswal, MD
Sandip Biswal, MD
Radiologist
Adjunct Clinical Professor, Radiology
Sanjiv Sam Gambhir, MD, PhD
Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov