Status:
COMPLETED
F-18 Sodium Fluoride in Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Background: * Evaluating response to therapy in prostate cancer is limited by the inability to quantify bony metastatic disease * F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localiz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01240551
Start Date
November 30 2010
End Date
May 31 2013
Last Update
November 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892