NCT05470699

RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess imaging performance of the fluorine F 18 piflufolastat (\[18F\]-DCFPyL) PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with prostate cancer. SECONDARY OBJECTIVE: I. To determine the feasibility of generating a biology-guided radiotherapy (BgRT) plan using X1 RMRS-acquired \[18F\]-DCFPyL PET data derived from the imaging-only session at the studied dose level. OUTLINE: Patients receive \[18F\]-DCFPyL intravenously (IV) and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per standard of care (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. After completion of study, patients are followed up within 72 hours.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
OTHER	Fluorine F 18 Piflufolastat	Given IV
DEVICE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-03-29
• Completion: 2026-04-13
• First posted: 2022-07-22
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study