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

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.

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.

Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.

The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.

• Active Comparator: TC-MDP Bone Scan
  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
  Intervention: Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP
• Experimental: F18-Fluoride PET/CT
  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
  Intervention: Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP

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