RefleXion PET/CT Imaging for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Psychiatric disorder, Substance abuse, Weight limit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

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

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.

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 Overview The 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

Group I: Device ([18F]-FDG PET-CT, X1 RMRS PET-CT) Experimental Treatment 4 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive planning using positron emission tomography for locally advanced lung cancer: A feasibility study. Kelsey, CR., Christensen, JD., Chino, JP., et al.[2017]

PET/CT imaging is the most accurate tool for staging and restaging cancer, outperforming PET or CT alone.

Future advancements in PET/CT's effectiveness will rely more on the development of targeted imaging probes for personalized cancer therapies rather than just improvements in imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical PET/CT imaging: promises and misconceptions. Czernin, J., Auerbach, MA.[2016]

In a study of 52 PET/CT scans involving 47 breast cancer patients, PET/CT significantly influenced clinical management decisions, with 78.8% of scans leading to changes in patient management, including major changes in 34.6% of cases.

The use of PET/CT not only helped in accurately staging and restaging breast cancer but also contributed to a 5-year survival rate of 72.3% for the overall group, highlighting its potential to improve patient outcomes by avoiding unnecessary invasive diagnostic tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of [18F]FDG-PET/CT on Clinical Management Decisions in Breast Cancer Patients-A PET/CT Registry Study. Werner, S., Sekler, J., Gückel, B., et al.[2023]

In a study of 46 patients undergoing immunotherapy for various cancers, 61% developed immune-related adverse events (irAEs) detectable by 18F-FDG PET/CT, highlighting its importance in monitoring treatment effects.

The most common irAE detected was enteritis/colitis, occurring in 28.2% of patients, indicating that PET/CT can effectively identify significant inflammatory responses associated with immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. Tatar, G., Alçin, G., Sengul Samanci, N., et al.[2022]

A review of 36 studies found a positive association between radiation from computed tomography (CT) scans and an increased risk of cancer, particularly in children and young adults, highlighting the need for careful consideration of imaging in these populations.

While the overall risk of cancer from low-dose radiation exposure (< 50 milli-Sieverts) remains uncertain, the review suggests that the benefits of clinically justified scans for colorectal cancer follow-up may outweigh the risks, indicating a need to revise current follow-up guidelines for better management of metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation risks associated with serial imaging in colorectal cancer patients: should we worry? Oh, JS., Koea, JB.[2021]

Current estimates suggest that the risk of cancer induction from CT scans is very low, nearly at background levels, but there is significant uncertainty in these predictions.

It is important to communicate the benefits of CT imaging alongside the risks of radiation exposure, as reducing radiation doses further could compromise the quality of necessary medical images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current knowledge on tumour induction by computed tomography should be carefully used. Candela-Juan, C., Montoro, A., Ruiz-Martínez, E., et al.[2022]

Immune checkpoint inhibitors (ICIs) have significantly improved outcomes for patients with advanced cancers, leading to more long-term survivors, but these treatments require frequent CT scans that expose patients to considerable radiation.

In a review of 39 clinical trial protocols, it was found that after 10 years of participation, the lifetime cancer risk from radiation exposure due to repeated CT scans could increase to nearly 10% for women and about 6% for men, suggesting a need for adjusted imaging protocols to minimize risks for long-term survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconsider radiation exposure from imaging during immune checkpoint inhibitor trials to reduce risk of secondary cancers in long-term survivors? Knapen, DG., de Groot, DJA., Kwee, TC., et al.[2020]

Between 2000 and 2008, the excess lifetime risks (ELRs) of developing radiation-related cancer from CT scans in individuals under 20 years old were significantly reduced by 50-70% compared to earlier years, due to improved dose reduction practices.

Despite the reduction in ELRs, projections indicate that the 130,750 CT scans performed in the UK in 2015 could lead to 64 future cancers, and if current scanning practices continue, approximately 300 future cancers could arise from scans conducted between 2016 and 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected cancer risks potentially related to past, current, and future practices in paediatric CT in the United Kingdom, 1990-2020. Journy, NM., Lee, C., Harbron, RW., et al.[2018]

PET scanning with (18)F-fluorodeoxyglucose ((18)FDG) enhances cancer diagnosis and treatment by providing functional imaging that complements traditional CT and MR imaging, allowing for better localization and assessment of tumors.

The introduction of combined PET/CT scanners has improved the accuracy of imaging by allowing anatomical and functional images to be obtained in a single session, which is crucial for guiding cancer therapies and monitoring treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided cancer therapy using PET/CT. Yap, JT., Carney, JP., Hall, NC., et al.[2019]

The recent introduction of PET/CT hardware fusion has shown significant advantages over PET alone, particularly in providing complementary information for staging and managing oncology patients.

Evidence suggests that PET/CT can lead to changes in management plans for cancer patients, highlighting its efficacy in improving patient care and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT in oncology--a major advance. Wechalekar, K., Sharma, B., Cook, G.[2016]

Hybrid imaging technologies, particularly PET/CT, effectively combine functional and anatomical information, significantly enhancing patient management in oncology after a decade of clinical evaluation.

Future advancements in acquisition techniques and data processing are expected to make PET/CT faster and more dose-efficient, solidifying its role as a crucial tool in modern clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of hybrid imaging-part 2: PET/CT. Beyer, T., Townsend, DW., Czernin, J., et al.[2021]

Positron emission tomography (PET) using fluorine 18 fluorodeoxyglucose (FDG) is a valuable tool for diagnosing and staging cancer, as it provides functional imaging that complements traditional anatomical imaging techniques like computed tomography (CT).

The introduction of combined PET/CT scanners allows for simultaneous acquisition of anatomical and functional images, improving the accuracy of cancer diagnosis and treatment monitoring, with over 800 such scanners currently in use worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT: form and function. Blodgett, TM., Meltzer, CC., Townsend, DW.[2022]

PET-CT is becoming the standard imaging method for cancer staging and therapy monitoring because it measures molecular activity, like glucose metabolism, which is crucial for understanding tumor behavior.

The use of PET is expected to grow significantly, with projections of 2000 to 3000 examinations per million inhabitants annually, and it may also expand into other areas such as cardiac imaging for better assessment of heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Positron emission tomography (PET)--current state of the art and future perspectives]. von Schulthess, GK.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

A role of FDG-PET/CT for response evaluation in metastatic breast cancer? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

¹⁸F-FDG PET/CT and Colorectal Cancer: Value of Fourth and Subsequent Posttherapy Follow-up Scans for Patient Management. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Adaptive planning using positron emission tomography for locally advanced lung cancer: A feasibility study. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical PET/CT imaging: promises and misconceptions. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of [18F]FDG-PET/CT on Clinical Management Decisions in Breast Cancer Patients-A PET/CT Registry Study. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation risks associated with serial imaging in colorectal cancer patients: should we worry? [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Current knowledge on tumour induction by computed tomography should be carefully used. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Reconsider radiation exposure from imaging during immune checkpoint inhibitor trials to reduce risk of secondary cancers in long-term survivors? [2020]

10. England pubmed.ncbi.nlm.nih.gov

Projected cancer risks potentially related to past, current, and future practices in paediatric CT in the United Kingdom, 1990-2020. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Image-guided cancer therapy using PET/CT. [2019]

12. England pubmed.ncbi.nlm.nih.gov

PET/CT in oncology--a major advance. [2016]

13. Germany pubmed.ncbi.nlm.nih.gov

The future of hybrid imaging-part 2: PET/CT. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

PET/CT: form and function. [2022]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Positron emission tomography (PET)--current state of the art and future perspectives]. [2016]