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

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Automated Breast Radiation Therapy?

Research shows that using MRI (a type of imaging that provides detailed pictures of the inside of the body) to guide radiation therapy can improve how well the treatment targets the tumor, especially in breast cancer. This approach helps in reducing the amount of healthy tissue exposed to radiation, potentially lowering side effects. ^{1 2 3 4 5}

Is MR-guided radiation therapy safe for humans?

Research on MR-guided radiation therapy, including for breast cancer, suggests it can reduce the amount of healthy tissue exposed to radiation, potentially lowering the risk of side effects. This approach is being studied to improve safety by making treatment more precise and minimizing damage to surrounding tissues. ^{4 6 7 8 9}

How does Automated Breast Radiation Therapy differ from other breast cancer treatments?

Automated Breast Radiation Therapy is unique because it uses MRI-guided radiation, which provides better soft-tissue contrast and allows for real-time adaptation to changes in the tumor's position during treatment. This approach can improve the precision of radiation delivery compared to traditional methods that rely on CT scans. ^{1 2 3 10 11}

What is the purpose of this trial?

In the proposed research study, we are investigating the feasibility of integrating automated planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive radiation treatment. However, these on-line automation tools require further technical refinement and clinical validation. The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.

Research Team

Robert Dinniwell, M.D.

Principal Investigator

Princess Margaret Cancer Centre

Tom Purdie, Physicist

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. [2022]

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

MRI-guided Radiation Therapy: An Emerging Paradigm in Adaptive Radiation Oncology. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of image acquisition time on registration, delineation and image quality for magnetic resonance guided radiotherapy of prostate cancer patients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. [2021]

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

How Does MR Imaging Help Care for My Breast Cancer Patient? Perspective of a Radiation Oncologist. [2018]

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

MRI guidance for accelerated partial breast irradiation in prone position: imaging protocol design and evaluation. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The transformation of radiation oncology using real-time magnetic resonance guidance: A review. [2022]

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

A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. [2020]

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

Improved Ipsilateral Breast and Chest Wall Sparing With MR-Guided 3-fraction Accelerated Partial Breast Irradiation: A Dosimetric Study Comparing MR-Linac and CT-Linac Plans. [2022]

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

Quantification of intra-fraction motion in breast radiotherapy using supine magnetic resonance imaging. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

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