A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- 68Ga-PSMA-11
- Conditions
- Prostate Cancer
- Sponsor
- Andrei Iagaru
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Detailed Description
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer. Exploratory Objective: * Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy * Correlation of 68Ga RM2 and Gleason score at biopsy
Investigators
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Suspected prostate cancer
- •Planned prostate biopsy
- •Able to provide written consent
- •Karnofsky performance status of 50 (or ECOG/WHO equivalent)
Exclusion Criteria
- •Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- •Metallic implants (contraindicated for MRI)
Arms & Interventions
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
Intervention: 68Ga-PSMA-11
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
Intervention: 68Ga RM2
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
Intervention: 68Ga-PSMA-11
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
Intervention: Investigational PET scanner coils and software
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
Intervention: 68Ga RM2
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
Intervention: Investigational PET scanner coils and software
Outcomes
Primary Outcomes
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
Time Frame: Up to approximately 2 hours to complete each scan
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).