Status:
COMPLETED
Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
Lead Sponsor:
Mayo Clinic
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.
Detailed Description
High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the pros...
Eligibility Criteria
Inclusion
- 1\. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.
Exclusion
- Patients who already received primary treatment or neo-adjuvant therapy.
- Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.
- Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement \[e.g., tremor, dystonia\]).
- Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
- Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
- Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03404648
Start Date
November 1 2017
End Date
January 23 2020
Last Update
February 8 2021
Active Locations (1)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259