A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Overview
- Phase
- Phase 1
- Intervention
- 68-Ga RM2
- Conditions
- Prostate Cancer
- Sponsor
- Andrei Iagaru
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.
Detailed Description
Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.
Investigators
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Known prostate cancer
- •Planned HIFU or HDR local therapy
- •Able to provide written consent
- •Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: 68-Ga RM2
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: 68-Ga PSMA11
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: Investigational software and coils in PET/MR Scan
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: PET/MRI
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: 68-Ga RM2
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: 68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: Investigational software and coils in PET/MR Scan
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Intervention: PET/MRI
Outcomes
Primary Outcomes
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
Time Frame: Up to approximately 2 hours to complete each scan
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.