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

NCT03949517 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-01-30

Study results available
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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.

Conditions

Interventions

DRUG

68-Ga RM2

Radioactive agent

DRUG

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

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY

  • Andrei Iagaru

    lead OTHER

Principal Investigators

  • Andrei H Iagaru, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2022-03-07
Completion
2022-03-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03949517 on ClinicalTrials.gov