SUSPENDED

RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-15
Study Completion:2026-08-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05844306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Age: \>= 21 years
  3. * Patients with malignancies (abdominal/pelvic/thoracic/head and neck/breast tumors) undergoing SOC \[18F\]-FDG PET-CT for diagnostic and/or radiotherapy planning purposes
  4. * Patients should be scheduled for \[18F\]-FDG PET-CT prior to study entry
  1. * Known psychiatric or substance abuse disorder that would interfere with conduct of the study
  2. * Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
  3. * Lung parenchymal and bone tumors will be excluded as their imaging characteristics were evaluated in a previous study

Contacts and Locations

Principal Investigator

Jeffrey Y Wong
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Jeffrey Y Wong, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2026-08-28

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2026-08-28

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm