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

Andrei Iagaru14 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

68Ga RM2DRUG

PET radiopharmaceutical

68Ga-PSMA-11DRUG

PET radiopharmaceutical

Investigational PET scanner coils and softwareDEVICE

GE Healthcare non-approved PET scanner coils and software

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings

Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

Time frame: Up to approximately 2 hours to complete each scan

Data from ClinicalTrials.gov

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