Status:
COMPLETED
Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Bone Metastases
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone met...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer usin...
Eligibility Criteria
Inclusion
- Any ethnic group
- Pathologically proven prostate cancer with high risk for bone metastases
- Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA \> 10 ng/mL
- Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
- Patients Eastern Cooperative Oncology Group (ECOG) performance is =\< 1
Exclusion
- Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
- Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
- Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00956163
Start Date
March 1 2010
End Date
May 1 2014
Last Update
July 2 2014
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114