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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
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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