NCT03809078

68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

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

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68Ga RM2	PET radiopharmaceutical
DRUG	68Ga-PSMA-11	PET radiopharmaceutical
DEVICE	Investigational PET scanner coils and software	GE Healthcare non-approved PET scanner coils and software

Timeline

• Start date: 2019-01-14
• Primary completion: 2022-03-08
• Completion: 2022-03-08
• First posted: 2019-01-18
• Last updated: 2024-01-11
• Results posted: 2024-01-11

Locations

1 site across 1 country: United States

Regulatory

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