Automated MR-Guided Radiation for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Males, Partial breast radiation, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for breast cancer using advanced imaging technology. The goal is to enhance precision and adaptability without increasing radiation exposure. It targets women with breast cancer who have undergone surgery or chemotherapy and are scheduled for standard whole breast radiation therapy. Participants must be able to provide written consent. The trial aims to improve treatment options for early-stage breast cancer patients. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this automated breast radiation therapy is safe?

Research has shown that a new method using MRI-guided technology for breast cancer radiation therapy is being tested to improve safety. This approach aims to enhance treatment accuracy, reducing the risk of damaging nearby healthy tissue. Studies indicate that MRI-guided radiation can target smaller areas, potentially leading to fewer side effects for patients. Although the technology is still under development, early results suggest it could be a well-tolerated option for breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Automated Breast Radiation Therapy is unique because it combines advanced imaging techniques like MRI and CT scans with Intensity-Modulated Radiation Therapy (IMRT) to precisely target breast cancer cells. Unlike traditional radiation therapies, which often rely on static imaging, this method allows for real-time adjustments during treatment, increasing precision and potentially reducing damage to surrounding healthy tissues. Researchers are excited about this approach because it promises to improve treatment accuracy and outcomes, making the therapy more effective and less invasive for patients.

What evidence suggests that this automated breast radiation therapy is effective for breast cancer?

Research has shown that automated MR-guided radiation therapy for breast cancer improves treatment accuracy by adjusting to changes in the patient's body. This trial will evaluate the effectiveness of this method, which helps protect healthy tissues from unnecessary radiation, offering a significant advantage. Studies have found that MR-guided systems can focus on the cancer more precisely, enhancing treatment effectiveness. Additionally, these systems use artificial intelligence (AI) to identify the edges of the breast accurately, aiding in precise radiation delivery. Overall, this approach offers hope for more effective and safer radiation treatment for breast cancer patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Robert Dinniwell, M.D.

Principal Investigator

Princess Margaret Cancer Centre

Tom Purdie, Physicist

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

This trial is for female patients over 18 with any stage of breast cancer, who will undergo standard whole breast radiation therapy. It's open to those who've had surgery or chemotherapy for any cancer type and can consent in writing.

Inclusion Criteria

I have had surgery or chemotherapy for cancer before.

Able to provide a written informed consent

I will receive standard breast radiation therapy in one of the specified dose plans.

Exclusion Criteria

I am male.

I received lower than the standard dose of radiation for my breast.

I am unable to understand and give consent for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive MR-guided radiation therapy using automated planning tools for breast IMRT treatment

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after radiation treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Automated Breast Radiation Therapy

Trial Overview The study tests an automated planning tool that uses MR images from a new MR-guided linac for on-line adaptive radiation treatment, aiming to refine this technology and validate its clinical use without extra ionizing radiation.

How Is the Trial Designed?

Group I: IMRT + CT + MR scan Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Published Research Related to This Trial

The first clinical implementation of online adaptive magnetic resonance image-guided radiation therapy (MR-IGRT) was successfully conducted on 5 patients with abdominopelvic cancers, demonstrating the feasibility of real-time adaptive planning during treatment.

Out of 170 treatment fractions in an expanded cohort, 30.6% required online reoptimization, indicating that adapting treatment plans based on daily imaging can effectively address changes in tumor size and patient anatomy, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Acharya, S., Fischer-Valuck, BW., Kashani, R., et al.[2022]

MRI-guided radiation therapy (RT) offers significant advantages over traditional CT-based methods, including better soft-tissue contrast and the ability to visualize organ motion, which can enhance treatment planning and monitoring.

Emerging technologies in MRI-guided RT, such as real-time adaptive treatment and MRI-derived biomarkers, have the potential to improve cancer treatment by allowing for adjustments based on physiological changes during therapy, although challenges like image distortion and the need for standardized imaging protocols remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Radiation Therapy: An Emerging Paradigm in Adaptive Radiation Oncology. Otazo, R., Lambin, P., Pignol, JP., et al.[2022]

Neoadjuvant partial breast irradiation (PBI) is being researched to minimize the amount of breast tissue exposed to radiation, which could lower the risk of long-term side effects from treatment.

Magnetic resonance (MR)-guided radiotherapy, particularly using MR-linac systems, may enhance tumor visibility during treatment, potentially allowing for even more precise targeting and reduced radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. Groot Koerkamp, ML., Vasmel, JE., Russell, NS., et al.[2021]

The development of a 0.35 T MR-Linac system allows for advanced MR-guided radiation therapy, integrating daily MR imaging for better soft-tissue contrast and enabling precise patient setup and treatment plan adjustments.

This hybrid system enhances treatment precision through features like automated beam gating and structure tracking, potentially leading to reduced margins and increased radiation doses to tumors while minimizing damage to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical design and concept of a 0.35 T MR-Linac. Klüter, S.[2020]

The newly developed end-to-end quality assurance (QA) workflow for MR-guided online adaptive radiation therapy (MRgOART) takes only 10 minutes to complete and effectively checks the performance and connectivity of all components involved, ensuring safe and accurate treatment delivery.

This QA process has successfully identified communication issues and discrepancies in isocenter shifts, allowing for timely resolutions before patient treatment, thus enhancing the reliability of MRgOART in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. Chen, X., Ahunbay, E., Paulson, ES., et al.[2020]

MRI-guided radiation therapy (RT) is revolutionizing cancer treatment by improving precision in target identification and treatment delivery, which enhances the overall effectiveness of cancer care.

This innovative approach not only transforms clinical workflows and quality assurance in RT but also opens up new research opportunities in oncology, indicating a significant shift in how radiation therapy may be conducted in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The transformation of radiation oncology using real-time magnetic resonance guidance: A review. Hall, WA., Paulson, ES., van der Heide, UA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9826896/

Adaptive radiotherapy for breast cancer - PMC Adaptive radiotherapy offers potential clinical benefits for breast cancer patients. Advantages of MR-guided adaptive radiotherapy are expected in the ...

2. clinicaltrial.be clinicaltrial.be/en/details/12123?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Automated Breast Radiation Therapy Using an MR-Guided ... The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S105342962300070X

Articles The Future of MR-Guided Radiation Therapy This article summarizes limitations of current available integrated MRIgRT systems and gives an outlook about scientific developments to further expand the use ...

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Automated MR-Guided Radiation for Breast Cancer Research on MR-guided radiation therapy, including for breast cancer, suggests it can reduce the amount of healthy tissue exposed to radiation, potentially ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12410574/

Artificial intelligence as treatment support in breast cancer AI also possesses the ability to detect key features of the breast as it has achieved 97.7 % success in the identification of breast boundaries, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12341621/

Artificial intelligence in breast cancer radiotherapy Artificial intelligence (AI) is being incorporated in several breast cancer care domains, including for radiation therapy (RT).

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630822001227

Adaptive radiotherapy for breast cancer MR-based ART might allow for smaller planning target volumes (PTVs). PTV margins up to 10 mm have been calculated as being necessary to take into account ...

8. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(24)00136-8/fulltext

Potential of MRI in Assessing Treatment Response After ... This review highlights tumor volume measurements, ADC, and TTE as promising MRI metrics for assessing treatment response post-NRT in breast cancer.