18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques

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