CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 34 enrolled / 34 target
Drug / intervention
Computed Tomography +2 moreprocedure
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/NCT05470699
NCT05470699N/AActiveUpdate Overdue (0.7/mo)Completion was 39mo ago

A Prospective Study of the RefleXion [18F]- DCFPyL PET-CT Subsystem Imaging Performance in Patients With Prostate Cancer

City of Hope Medical Center·interventional·Posted Jul 22, 2022·Updated Jun 2, 2026

In Brief

A clinical study evaluating Computed Tomography, Fluorine F 18 Piflufolastat, and 1 other intervention for Prostate Carcinoma. Active but no longer recruiting, targeting 34 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18F\]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18F\]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care \[18F\]-DCFPyL-PET-CT with the \[18F\]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActive
20232024202520262027
First PostedJul 22, 2022
Enrollment StartAug 29, 2022
Primary CompletionMar 29, 2023
Study CompletionMar 5, 2027
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.9 years ago

Arms & Interventions

Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)experimental

Patients receive \[18F\]-DCFPyL IV and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

Procedure: Computed TomographyOther: Fluorine F 18 PiflufolastatDevice: Positron Emission Tomography

Interventions

Computed Tomographyprocedure

Undergo PET/CT

Fluorine F 18 Piflufolastatother

Given IV

Positron Emission Tomographydevice

Undergo PET/CT