RefleXion PET/CT Imaging for Cancer
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.
What data supports the idea that RefleXion PET/CT Imaging for Cancer is an effective treatment?
The available research shows that RefleXion PET/CT Imaging is effective in managing cancer, particularly in breast cancer patients. It provides more accurate staging and restaging compared to conventional imaging methods, which helps in making better treatment decisions. For instance, in breast cancer, PET/CT was able to detect disease progression earlier, leading to timely changes in treatment that improved patient survival. In a study, PET/CT led to management changes in about 79% of cases, and these changes were linked to a 5-year survival rate of 72.3% for the whole study group. This suggests that PET/CT can significantly impact patient outcomes by providing more reliable information for treatment planning.12345
What safety data exists for RefleXion PET/CT Imaging for Cancer?
The safety data for RefleXion PET/CT Imaging, which involves PET and CT scans, includes concerns about radiation exposure. Studies indicate a minor increased risk of cancer from ionizing radiation in medical imaging, particularly with repeated CT scans. The risk is higher in children and young adults compared to older patients. However, the estimated extra risks of cancer are close to the background level, and there is significant uncertainty in these estimates. It is important to balance the benefits of imaging with the potential risks, and adaptive imaging intervals may be considered to reduce radiation exposure, especially in long-term cancer survivors.678910
Is the treatment Medical Device Usage and Evaluation (EFT) a promising treatment for cancer?
The RefleXion PET/CT Imaging is a promising treatment for cancer because it combines two powerful imaging techniques, PET and CT, to provide detailed pictures of the body's organs and tissues. This helps doctors better diagnose, plan treatment, and monitor how well the treatment is working, making it a valuable tool in cancer care.1112131415
Research Team
Jeffrey Wong
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults over 21 with various cancers who need standard PET-CT scans using [18F]-FDG for diagnosis or radiotherapy planning. It's not suitable for those with psychiatric/substance abuse issues, weigh over 450 pounds, or have lung/bone tumors previously studied.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Computed Tomography
- Medical Device Usage and Evaluation
- Positron Emission Tomography
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator