20 Participants Needed

RefleXion PET/CT Imaging for Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 Y.C. Wong, M.D. | City of Hope

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

I am 21 years old or older.
Documented informed consent of the participant and/or legally authorized representative
I am undergoing a PET-CT scan for my cancer diagnosis or treatment planning.
See 1 more

Exclusion Criteria

Known psychiatric or substance abuse disorder that would interfere with conduct of the study
I weigh less than or equal to 450 pounds.
My cancer is not in the lung tissue or bones.

Treatment Details

Interventions

  • Computed Tomography
  • Medical Device Usage and Evaluation
  • Positron Emission Tomography
Trial OverviewThe study compares the RefleXion Medical Radiotherapy System (RMRS) imaging to standard PET-CT scans in cancer patients. Researchers aim to enhance real-time radiotherapy targeting and reduce the number of scans needed by improving RMRS imaging quality.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)Experimental Treatment4 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

FDG-PET/CT is a highly accurate method for staging and evaluating response in metastatic breast cancer, showing greater sensitivity in detecting disease progression compared to conventional imaging methods like CT and bone scintigraphy.
Using FDG-PET/CT for monitoring treatment response has been associated with a survival benefit, as it allows for earlier detection of disease progression, leading to timely treatment adjustments that may enhance treatment efficacy.
A role of FDG-PET/CT for response evaluation in metastatic breast cancer?Hildebrandt, MG., Naghavi-Behzad, M., Vogsen, M.[2022]
In a study of 822 colorectal cancer patients, those who underwent four or more follow-up PET/CT scans showed significant changes in treatment plans after 34.2% of the scans, highlighting the scans' value in managing patient care.
The fourth and subsequent PET/CT scans provided important prognostic information, as patients with positive scan results had significantly lower overall survival rates compared to those with negative scans, indicating the scans' role in assessing disease recurrence and metastasis.
¹⁸F-FDG PET/CT and Colorectal Cancer: Value of Fourth and Subsequent Posttherapy Follow-up Scans for Patient Management.Marcus, C., Marashdeh, W., Ahn, SJ., et al.[2016]
Adaptive planning using PET-CT in radiation therapy for locally advanced non-small cell lung cancer was found to be feasible, with 30 out of 33 enrolled patients initiating treatment and interim PET-CT showing various responses to therapy.
This approach allowed for significant dose reductions to normal tissues like the lungs, heart, and esophagus, compared to traditional planning methods, enhancing safety while targeting residual cancer effectively.
Adaptive planning using positron emission tomography for locally advanced lung cancer: A feasibility study.Kelsey, CR., Christensen, JD., Chino, JP., et al.[2017]

References

A role of FDG-PET/CT for response evaluation in metastatic breast cancer? [2022]
¹⁸F-FDG PET/CT and Colorectal Cancer: Value of Fourth and Subsequent Posttherapy Follow-up Scans for Patient Management. [2016]
Adaptive planning using positron emission tomography for locally advanced lung cancer: A feasibility study. [2017]
Clinical PET/CT imaging: promises and misconceptions. [2016]
Influence of [18F]FDG-PET/CT on Clinical Management Decisions in Breast Cancer Patients-A PET/CT Registry Study. [2023]
Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. [2022]
Radiation risks associated with serial imaging in colorectal cancer patients: should we worry? [2021]
Current knowledge on tumour induction by computed tomography should be carefully used. [2022]
Reconsider radiation exposure from imaging during immune checkpoint inhibitor trials to reduce risk of secondary cancers in long-term survivors? [2020]
Projected cancer risks potentially related to past, current, and future practices in paediatric CT in the United Kingdom, 1990-2020. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Image-guided cancer therapy using PET/CT. [2019]
PET/CT in oncology--a major advance. [2016]
The future of hybrid imaging-part 2: PET/CT. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
PET/CT: form and function. [2022]
[Positron emission tomography (PET)--current state of the art and future perspectives]. [2016]