MRIdian® Linac for Breast Cancer

(CONFIRM Trial)

Recruiting at 1 trial location

Overseen By Raymond Mak, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Allergy to gadolinium, Severe claustrophobia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

70 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 MRIdian® Linac treatment for breast cancer?

The MRIdian® Linac system has been shown to provide precise targeting of tumors while sparing healthy organs in other cancers, like hepatobiliary and pancreatic cancers, due to its real-time imaging and adaptive radiotherapy capabilities. This suggests it could be effective for breast cancer by improving dose distribution and minimizing damage to surrounding healthy tissue. ^{1 2 3 4 5}

Is the MRIdian® Linac system safe for use in humans?

The MRIdian® Linac system has been used in clinical settings for various cancers, including hepatobiliary and pancreatic cancers, with a focus on precise targeting and minimizing exposure to healthy tissues. Safety measures such as real-time monitoring and adaptive radiotherapy are in place to ensure patient safety during treatment. ^{1 2 6 7 8}

How is the MRIdian® Linac treatment for breast cancer different from other treatments?

The MRIdian® Linac treatment is unique because it combines MRI imaging with radiation therapy, allowing for real-time visualization of soft tissues and adaptive radiation planning during treatment. This means the radiation can be precisely targeted to the tumor while minimizing exposure to surrounding healthy tissues, which is not possible with traditional radiation therapy methods. ^{1 2 3 4 9}

What is the purpose of this trial?

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Research Team

Raymond Mak, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with certain cancers (like breast, stomach, and laryngeal) who need radiation treatment. They must be able to give consent and have a performance status that allows daily activities with effort or better. People can't join if they can't have an MRI, are severely claustrophobic, anxious, or allergic to MRI contrast agents.

Inclusion Criteria

Participants must have histologically or cytologically confirmed malignancy requiring radiation

Ability to understand and the willingness to sign a written informed consent document.

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

Exclusion Criteria

You are unable to have an MRI.

There may be additional criteria for exclusion related to your specific disease.

If you are not going to receive a contrast, your kidney function will not affect your eligibility.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive MR-image guided radiation and chemotherapy as per disease site standards

5 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

1 year

Treatment Details

Interventions

• Viewray MRIdian® Linac

Trial Overview The study tests the safety of using MRIdian Linear Accelerator guided by MRI alongside chemotherapy in treating gastric and breast cancer patients. It aims to see how well this advanced technology targets tumors during radiation therapy.

Participant Groups

Group I: Phase I - Mantle Cell Lymphoma Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Group II: Phase I - Larynx Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Group III: Phase I - Gastric Cancer Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Group IV: Phase I - Breast Cancer Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Group V: Phase I - Bladder Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Viewray MRIdian® Linac is already approved in United States for the following indications:

Approved in United States as ViewRay MRIdian Linac for:

• Lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

The MRIdian® MR linear accelerator in the UK has successfully implemented Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for treating hepatobiliary cancers, allowing for precise targeting and real-time adjustments during treatment for 50 patients in just five months.

SMART offers significant advantages such as excellent soft tissue visualization, daily recontouring of targets, and automatic respiratory-gated treatment delivery, making it suitable for complex tumors that may not be treatable with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Stereotactic MRI-Guided Adaptive Radiotherapy (SMART) for Hepatobiliary and Pancreatic Cancers in the United Kingdom - Fifty in Five. Gaya, A., Camilleri, P., Nash, A., et al.[2021]

The installation of the MRI-guided radiotherapy system (MRIdian) allows for real-time monitoring and adaptive radiotherapy (ART), which optimizes tumor targeting while minimizing exposure to healthy organs.

The system's capability to perform gated-radiotherapy based on real-time Cine-MRI enhances treatment precision, although patient-specific quality assurance (QA) activities are limited due to patients remaining in the treatment couch during planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[On-line Adaptive Radiotherapy Using MRI-Guided Technique]. Okamoto, H., Sakasai, T., Nishioka, S., et al.[2019]

Using a longitudinal magnetic field geometry in MRI-Linac systems significantly reduces the dose to the ipsilateral lung and heart by 17.2% and 6%, respectively, while also limiting the spread of secondary electrons, which enhances safety for patients undergoing breast radiotherapy.

The transverse magnetic field configuration improves dose homogeneity within the planning target volume (PTV) and reduces mean doses to the contralateral breast and chest wall skin by up to 28.1%, indicating that both geometries can optimize treatment effectiveness while minimizing harm to surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast dosimetry in transverse and longitudinal field MRI-Linac radiotherapy systems. Mahdavi, SR., Esmaeeli, AD., Pouladian, M., et al.[2017]

The study successfully optimized imaging protocols for gynecologic high-dose-rate (HDR) brachytherapy using a magnetic resonance linear accelerator (MR-linac), demonstrating minimal geometric distortion (maximum of 0.96 mm) and acceptable reconstruction accuracy compared to traditional CT imaging.

A new workflow for patient treatment was developed and validated, showing that MR-linac imaging can effectively plan and deliver HDR brachytherapy, with treatment plans achieving over 95% dose coverage of the clinical target volume, indicating its clinical acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-Guided High-Dose-Rate Gynecologic Brachytherapy Using an MR-Linac as an MR Simulator: A Single Institutional Experience. Massock, W., Kim, Y., Dresner, MA., et al.[2023]

The MR-linac system demonstrated reliable performance in adaptive radiation therapy for gynecologic cancers, with over 90% of treatment plans passing quality assurance tests, indicating high accuracy and safety in treatment delivery.

Treatment durations were significantly shorter when using the position adaptation method (ATP) compared to the shape adaptation method (ATS), with median times of 30 minutes versus 42 minutes, respectively, enhancing the efficiency of the therapy process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation and Initial Experience With a 1.5 Tesla MR-Linac for MR-Guided Radiation Therapy for Gynecologic Cancer: An R-IDEAL Stage 1 and 2a First in Humans Feasibility Study of New Technology Implementation. Lakomy, DS., Yang, J., Vedam, S., et al.[2023]

A new method for online automatic 3D secondary dose calculation (SDC) for 1.5T MR-Linac systems was developed and validated, showing high accuracy with a median gamma passing rate of 98.9% compared to full dose calculations in clinical plans.

This method demonstrated effective performance in clinical settings, particularly for central target locations, but additional verification may be needed for cases with peripheral targets and fewer beams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic 3D Monte-Carlo-based secondary dose calculation for online verification of 1.5 T magnetic resonance imaging guided radiotherapy. Nachbar, M., Mönnich, D., Dohm, O., et al.[2022]

The Australian MRI-linac system was successfully commissioned with precise alignment of the radiation beam to the magnetic field, achieving a tolerance of 2 mm, which is crucial for accurate patient treatment.

The system demonstrated compliance with international standards for dose monitoring and beam profile symmetry, indicating its readiness for clinical applications in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Optimization and Commissioning of a High Field Inline MRI-Linac. Jelen, U., Dong, B., Begg, J., et al.[2020]

A 7-month longitudinal study of an MR-guided radiotherapy system showed that daily quality assurance procedures effectively monitored the system's accuracy, with isocenter accuracy averaging 1.6 mm across cardinal angles.

The system demonstrated stable performance in safety interlocks, output, and MLC positioning, indicating reliable dosimetric and mechanical stability, despite some drift in dose rate over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and longitudinal assessment of daily quality assurance for an MR-guided radiotherapy (MRgRT) linac. Mittauer, KE., Dunkerley, DAP., Yadav, P., et al.[2023]

The implementation of the MR-linac system for magnetic resonance-guided radiation therapy (MRgRT) at a single institution in Turkey has shown feasibility for routine clinical use, successfully treating 72 patients across 84 tumor sites with real-time imaging and adaptive radiation planning.

The system allowed for on-table adaptive radiation therapy (oART) in 93.2% of patients and utilized automated beam gating to manage breathing-related motion, demonstrating its potential to improve treatment precision and patient safety during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience. Sahin, B., Zoto Mustafayev, T., Gungor, G., et al.[2020]

References

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

Implementation of Stereotactic MRI-Guided Adaptive Radiotherapy (SMART) for Hepatobiliary and Pancreatic Cancers in the United Kingdom - Fifty in Five. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

[On-line Adaptive Radiotherapy Using MRI-Guided Technique]. [2019]

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

Breast dosimetry in transverse and longitudinal field MRI-Linac radiotherapy systems. [2017]

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

MRI-Guided High-Dose-Rate Gynecologic Brachytherapy Using an MR-Linac as an MR Simulator: A Single Institutional Experience. [2023]

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

Clinical Implementation and Initial Experience With a 1.5 Tesla MR-Linac for MR-Guided Radiation Therapy for Gynecologic Cancer: An R-IDEAL Stage 1 and 2a First in Humans Feasibility Study of New Technology Implementation. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Automatic 3D Monte-Carlo-based secondary dose calculation for online verification of 1.5 T magnetic resonance imaging guided radiotherapy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Dosimetric Optimization and Commissioning of a High Field Inline MRI-Linac. [2020]

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

Characterization and longitudinal assessment of daily quality assurance for an MR-guided radiotherapy (MRgRT) linac. [2023]

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

First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience. [2020]