NCT03949517

68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68-Ga RM2	Radioactive agent
DRUG	68-Ga PSMA11	Radioactive agent
DEVICE	Investigational software and coils in PET/MR Scan	Investigational software and coils in PET/MR Scan by General Electric Healthcare
PROCEDURE	PET/MRI	Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan

Timeline

• Start date: 2019-04-09
• Primary completion: 2022-03-07
• Completion: 2022-03-07
• First posted: 2019-05-14
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study