Primary outcome: Primary: Number of Participants With Present or Not Present Bone Metastasis — 30; 10; 0; 20 Participants
Study Design & Population
Study type
Interventional
Phase
Phase 2
Interventions
F-18 NaF (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
National Cancer Institute (NCI)
Primary completion
May 2013
Outcome Measures
Outcome
Result
p-value
PRIMARY Number of Participants With Present or Not Present Bone Metastasis
30; 10; 0; 20; 29; 9
—
SECONDARY Number of Participants With Adverse Events
1; 1
—
Summary
Background:
- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able to better measure the changes in the bone that may indicate that a certain type of cancer (such as prostate cancer) has spread to the bones.
Objectives:
* To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and their change over time and compare with clinical course, in individuals with prostate cancer.
* To determine the smallest amount of change in the bone tumors that F-18 NaF can accurately measure.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and have had imaging studies to determine whether the cancer has spread to their bones. Both patients with and without known bone involvement will be enrolled.
Design:
* Participants will be screened with a physical examination, medical history, and imaging studies, and will provide baseline blood samples to evaluate kidney function.
* For the study, participants will have two F-18 NaF PET/CT scans on separate days for baseline. These repeat scans will be used to determine the amount of change that is due to the imaging process alone (i.e. not due to the disease getting better or worse. Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection. Participants will be watched closely for side effects from the F-18 NaF until the scans are done, and will be asked to drink plenty of water to void the F-18 NaF from the body after the scans.
* As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8 months after the first scans and then one 10 to 14 months after the first scans. Participants will provide additional blood samples before the followup scans.
Eligibility Criteria
INCLUSION CRITERIA:
Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.
Participant must have:
A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc)
OR
Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc).
Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
EXCLUSION CRITERIA
Participants with severe claustrophobia unresponsive to oral anxiolytics.
Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit within the imaging gantry.
Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Data sourced from ClinicalTrials.gov (NCT01240551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.