CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
68-Ga RM2 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03949517
NCT03949517Phase 2Completed

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

Andrei Iagaru·interventional·Posted May 14, 2019·Updated Jan 30, 2024

In Brief

A Phase 2 clinical trial evaluating 68-Ga RM2, 68-Ga PSMA11, and 2 other interventions for Prostate Cancer. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGeneral Electric

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 14, 2019
Enrollment StartApr 9, 2019
Primary CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.1 years ago

Interventions

68-Ga RM2drug

Radioactive agent

68-Ga PSMA11drug

Radioactive agent

Investigational software and coils in PET/MR Scandevice

Investigational software and coils in PET/MR Scan by General Electric Healthcare

PET/MRIprocedure

Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan