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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer imaging method using a system called RefleXion. It compares this system to the usual imaging approach, which uses a small amount of radioactive sugar to detect cancer cells. The goal is to determine if the RefleXion system can improve imaging quality and reduce the number of scans needed for planning radiation treatment. Individuals with cancer scheduled for standard PET-CT scans might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative imaging research that could enhance future cancer treatment planning.

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 prior data suggests that the RefleXion Medical Radiotherapy System is safe for PET/CT imaging?

Research shows that the [18F]-FDG PET-CT scan used in this trial is safe. The radiation from this scan typically ranges from 14 to 30 mSv, a standard and safe level for medical imaging. Patients generally tolerate the [18F]-FDG tracer, a common substance in these scans, well.

No major reports link side effects specifically to [18F]-FDG PET-CT. This is significant because [18F]-FDG PET-CT is already widely used for cancer imaging, and its safety is well-documented.

Overall, past experience with [18F]-FDG PET-CT indicates it is safe for humans. This trial uses the RefleXion Medical Radiotherapy System to capture these images. While this system is new, the safety of the [18F]-FDG PET-CT component is well-understood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RefleXion PET/CT imaging technique because it offers a new way of evaluating cancer. Unlike traditional diagnostic methods, which rely on standard PET-CT scans to detect cancerous lesions, this approach uses an innovative device called X1 RMRS PET-CT. This device provides an imaging-only session that could enhance the accuracy of detecting PET avid lesions. By potentially improving how we visualize cancer, this technique could lead to better-tailored treatment plans and outcomes for patients.

What evidence suggests that the RefleXion Medical Radiotherapy System is effective for cancer imaging?

Research has shown that [18F]-FDG PET-CT scans excel at detecting various types of cancer. These scans often determine cancer stages and assist in treatment planning because they can identify cancer activity before a tumor changes size. Studies have found that PET-CT scans outperform regular CT scans in identifying certain issues, such as cancer spreading to the bones. In this trial, the RefleXion system uses these PET-CT scans to guide radiation therapy in real-time, potentially improving cancer treatment. By using signals from the PET scan, the RefleXion system aims to deliver radiation more accurately, targeting cancer cells while protecting healthy tissue. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey Wong

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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

Documented informed consent of the participant and/or legally authorized representative

I am 21 years old or older.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive [18F]-FDG injection and undergo SOC [18F]-FDG PET-CT imaging

Up to 72 hours

1 visit (in-person)

X1 RMRS PET-CT Imaging

Participants with at least one PET avid lesion undergo X1 RMRS PET-CT imaging-only session

Up to 72 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions

2-4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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