Overview

Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

Status:
Completed
Trial end date:
2020-01-23
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Choline
Criteria
Inclusion Criteria:

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 Criteria:

1. Patients who already received primary treatment or neo-adjuvant therapy.

2. 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.

3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm,
involuntary movement [e.g., tremor, dystonia]).

4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility
artifact and degrade image quality of mpMRI.

5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device
which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.

6. 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.