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: Brigham and Women's Hospital

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment that uses MRI (magnetic resonance imaging) to guide the process, combined with chemotherapy, to determine its safety and feasibility for people with breast and gastric cancer. The treatment employs a specific machine called the MRIdian Linear Accelerator (also known as ViewRay MRIdian Linac). Suitable candidates have a confirmed cancer diagnosis requiring radiation and can undergo an MRI. The trial aims to explore whether this approach can effectively target cancer while minimizing side effects. As an unphased trial, it offers patients the opportunity to contribute to pioneering research that could lead to innovative 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 the MRIdian Linac System is safe for treating cancer?

Research has shown that the Viewray MRIdian Linac is a promising tool for treating cancer with radiation. This machine uses MRI (magnetic resonance imaging) to guide the radiation, enabling doctors to target tumors more precisely while protecting nearby healthy tissue.

In terms of safety, the MRIdian Linac has been used for various cancers, and patients generally tolerate it well, with few reports of serious side effects. One advantage is the faster treatment completion compared to traditional radiation therapy. Some patients finish in just one week instead of several weeks, making it less stressful and more convenient.

The technology can adjust radiation doses in real-time during treatment, directing the radiation more accurately at the tumor and reducing the risk to healthy tissues.

Overall, evidence suggests that the MRIdian Linac is a safe and well-tolerated option for radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRIdian® Linac treatment because it offers a unique way to target tumors with precision. Unlike standard treatments that use conventional radiation techniques, MRIdian® Linac uses real-time MRI guidance to deliver radiation precisely to the cancerous area. This technique helps to spare healthy surrounding tissues and potentially reduces side effects, making it a promising option for a variety of cancers, including breast, larynx, bladder, gastric, and mantle cell lymphoma. The ability to adjust treatment in real time based on the tumor's movement or changes is a game-changer, offering more personalized and effective cancer care.

What evidence suggests that the MRIdian Linac System is effective for treating breast cancer?

Research has shown that the Viewray MRIdian Linac, which uses MRI-guided radiation, could be promising for treating breast cancer. In this trial, participants will receive MR-image guided radiation as part of the study treatment. This technology allows doctors to see the tumor in real time during treatment, enabling more precise targeting of the cancer. Early results suggest that this method is well-tolerated, with patients experiencing few side effects. The device can adjust the radiation dose during treatment, potentially leading to better outcomes by protecting healthy tissue. Although only a few studies have examined its effectiveness for breast cancer, this innovative approach could offer potential benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

Raymond Mak, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8892442/

Use of magnetic resonance image‐guided radiotherapy for ... Currently, there are limited studies to demonstrate the clinical effectiveness of MRI guided radiotherapy (MRIgRT) treatment for breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9911688/

MRI-LINAC: A transformative technology in radiation oncology The Viewray MRIdian has the faculty of real time intrafraction modulation of dose delivery by imaging during treatment delivery, and the Elekta Unity scanner ...

3. viewraysystems.com viewraysystems.com/for-patients/how-mridian-works/breast/

MRIdian SMART for Breast Cancer It showed that single-fraction HG-PBI was well tolerated and resulted in few adverse events. Study Specifics: Patients received postoperative single-fraction 20 ...

4. advancesradonc.com advancesradonc.com/article/S2452-1094(21)00012-9/fulltext

A Dosimetric Study Comparing MR-Linac and CT ... In this study, we compare the plan quality of ViewRay MRIdian Linac forward planned intensity modulated radiation therapy and TrueBeam ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405630819300692

Technical design and concept of a 0.35 T MR-Linac The 0.35 T MR-Linac combines a 6MV linac with onboard MR imaging. MR imaging provides superior soft-tissue contrast compared to X-ray IGRT.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04368702

CONFIRM: Magnetic Resonance Guided Radiation Therapy 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 ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)06746-3/fulltext

Implementing stereotactic accelerated partial breast ... Only MRIdian treatment times were collected since the ViewRay Cobalt system has been phased out and was dependent on source strength. Results.