RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

NCT05844306 | Suspended DMC FDA Device

• 3 other identifiers: 22668NCI-2023-01994P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Imaging performance of X1 RefleXion Medical Radiotherapy System (RMRS) positron emission tomography (PET)-computed tomography (CT) with the Imaging performance of the diagnostic fludeoxyglucose F-18 ([18F]-FDG) PET-CT

  One key metric will be the percent of patients with lesions identified on standard of care (SOC) PET-CT that are not identified on X1 (false negatives if considering SOC the true standard). For the SOC \[18F\]-FDG PET-CT, the maximum standard uptake value (SUV) and the greatest dimension in centimeters will be recorded for each PET avid malignant lesion identified by the nuclear medicine radiologist. The patient's radiation oncologist will interpret the X1 PET scan for the same metrics. Graphical presentations will be provided to compare SOC positive lesions and X1 positive lesions, and SOC positive lesions and X1 negative lesions with regards to lesion size, lesion location (lymph nodes, soft tissue, visceral organ) and SUV uptake. Descriptive statistics will be utilized to quantify results. Mean, standard deviation, interquartile range (IQR), and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables.

  Up to 72 hours

Secondary Outcomes (1)

• Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan

  Up to 72 hours

Study Arms (1)

Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Other: Medical Device Usage and Evaluation; Device: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo \[18F\]-FDG PET-CT

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

Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)

Fludeoxyglucose F-18 OTHER

Given via injection

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)

Medical Device Usage and Evaluation OTHER

Undergo X1 RMRS PET-CT

Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)

Positron Emission Tomography DEVICE

Undergo \[18F\]-FDG 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, PT

Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• 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 with malignancies (abdominal/pelvic/thoracic/head and neck/breast tumors) undergoing SOC \[18F\]-FDG PET-CT for diagnostic and/or radiotherapy planning purposes
• Patients should be scheduled for \[18F\]-FDG 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
• Lung parenchymal and bone tumors will be excluded as their imaging characteristics were evaluated in a previous study

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

Interventions

Fluorodeoxyglucose F18; Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jeffrey Y Wong

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 6, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)