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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809078
• Other study ID #: IRB-48151
• Secondary ID: PROS0091IRB-4815
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2019
• Est. completion date: March 8, 2022

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga RM2
PET radiopharmaceutical
• 68Ga-PSMA-11
PET radiopharmaceutical

Device:
• Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Andrei Iagaru	General Electric

Country where clinical trial is conducted

United States, 

References & Publications (1)

Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to approximately 2 hours to complete each scan