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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949517
• Other study ID #: IRB-48213
• Secondary ID: PROS0093IRB-4821
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 9, 2019
• Est. completion date: March 7, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68-Ga RM2
Radioactive agent
• 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

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, Davidzon GA, Aparici CM, Kunder C, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High-Intensity Focused Ultrasound Therapy. J Nucl Med. 2023 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained	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.	Up to approximately 2 hours to complete each scan