NCT05844306

RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

A Pilot Prospective Study of the RefleXion [18F]- FDG PET-CT Subsystem Imaging Performance in Patients With Various Malignancies

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) fludeoxyglucose F-18 (\[18F\]-FDG)- positron emission tomography (PET)-computed tomography (CT) imaging in patients with various cancers (malignancies). PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, \[18F\]-FDG. Because some cancers take up \[18F\]-FDG, cancer cells can be seen with PET. 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 RefleXion system is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The RMRS uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with FDG (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiotherapy that will target (in real time) the signal released from the \[18F\]-FDG-PET-CT tracer. Comparing the imaging from the standard of care \[18F\]-FDG-PET-CT with the \[18F\]-FDG 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 cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess imaging performance of the \[18F\]-FDG PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with various types of malignancies. SECONDARY OBJECTIVE: I. To determine the feasibility of generating a BgRT plan using X1 RMRS-acquired \[18F\]-FDG PET data derived from the imaging-only session at the studied dose level. OUTLINE: Patients receive \[18F\]-FDG injection and undergo SOC \[18F\]-FDG PET-CT on study. Patients with at least one PET avid lesion then undergo X1 RMRS PET-CT imaging-only session on study.

Conditions

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo \[18F\]-FDG PET-CT
OTHER	Fludeoxyglucose F-18	Given via injection
OTHER	Medical Device Usage and Evaluation	Undergo X1 RMRS PET-CT
DEVICE	Positron Emission Tomography	Undergo \[18F\]-FDG PET-CT

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-08-28
• Completion: 2026-08-28
• First posted: 2023-05-06
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study