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

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.

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