RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

NCT05470699 | Active Not Recruiting Results DMC FDA Device

• 3 other identifiers: 22189NCI-2022-05684P30CA033572
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)

  To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.

  Up to 72 hours after completion of scan

Secondary Outcomes (1)

• Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan

  Up to 72 hours

Study Arms (1)

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 Tomography; Other: Fluorine F 18 Piflufolastat; Device: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

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

Fluorine F 18 Piflufolastat OTHER

Given IV

Also known as: 18F-DCFPyL, Fluorine F 18 DCFPyL, Piflufolastat F 18, Piflufolastat F-18, Piflufolastat F18, Pylarify

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

Positron Emission Tomography DEVICE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Age \>= 21 years
• Patients undergoing SOC \[18F\]-DCFPyL PET-CT
• Patients should be scheduled for \[18F\]-DCFPyL PET-CT prior to study entry

You may not qualify if:

• Known psychiatric or substance abuse disorder that would interfere with conduct of the study
• Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

6262185265

Study Officials

• Jeffrey Y Wong

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: August 29, 2022
• Primary Completion: March 29, 2023
• Study Completion: April 13, 2026
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Locations

US (1)