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RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

NCT05844306 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Y Wong · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2026-08-28
Completion
2026-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844306 on ClinicalTrials.gov