MR-Guided Radiation Therapy for Cancer

(MRgRT Trial)

Overseen By Michael Milosevic, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

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 using magnetic resonance (MR) imaging to guide treatment, known as magnetic resonance-guided radiation therapy (MRgRT). The researchers aim to evaluate the effectiveness of this method and its impact on the workflow for the medical team at the Princess Margaret Cancer Centre. This treatment could potentially allow for more precise targeting of tumors during radiation therapy. Individuals already scheduled for imaging or treatment at the MRgRT facility may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve future cancer treatments.

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.

What prior data suggests that this magnetic resonance-guided radiation therapy is safe?

Research has shown that magnetic resonance-guided radiation therapy (MRgRT) is generally safe and well-tolerated. One study found that this type of radiation therapy carries a low risk of serious side effects. Another study demonstrated that treatments using MRgRT with a 1.5-Tesla machine were safe and well-tolerated by patients. Overall, these findings suggest that MRgRT offers a promising treatment option with a manageable safety profile for patients considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about magnetic resonance-guided radiation therapy (MRgRT) because it offers a more precise and adaptable approach to treating cancer. Unlike traditional radiation therapy, MRgRT uses real-time imaging to target tumors with greater accuracy, potentially sparing healthy tissue and reducing side effects. This method allows for adjustments during treatment based on tumor response and patient anatomy changes, potentially improving outcomes and making treatment more personalized.

What evidence suggests that magnetic resonance-guided radiation therapy is effective for cancer?

Research has shown that magnetic resonance-guided radiation therapy (MRgRT), which participants in this trial will receive, safely and effectively treats localized prostate cancer. Studies have found that MRgRT accurately targets cancerous tumors while protecting healthy tissue, reducing side effects. Some patients experienced temporary urinary and bowel issues, but these often improved over time. The treatment also carries a low risk of causing serious side effects. Overall, MRgRT is a promising cancer treatment that aims to minimize harm to healthy areas. ^{1 3 4 5 6}

Who Is on the Research Team?

Michael Milosevic, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can give informed consent and are scheduled to receive imaging or treatment at the Princess Margaret Cancer Centre's MRgRT facility. There are no specific exclusion criteria mentioned.

Inclusion Criteria

Planned to receive clinical intervention (imaging or treatment) in the MRgRT facility

Ability to provide informed consent

Exclusion Criteria

There are no specific criteria for exclusion or inclusion in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive magnetic resonance-guided radiation therapy (MRgRT)

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic resonance-guided radiation therapy (MRgRT)

Trial Overview The study focuses on assessing how well magnetic resonance-guided radiation therapy (MRgRT) works in a research setting and its effects on the clinical team's workflow at the cancer center.

How Is the Trial Designed?

Group I: Magnetic resonance - guided radiation therapy (MRgRT) Experimental Treatment 1 Intervention

Magnetic resonance (MR) - guided radiation therapy

Magnetic resonance-guided radiation therapy (MRgRT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as MRgRT for:

• Prostate cancer
• Rectal cancer
• Liver cancer
• Pancreatic cancer
• Lung cancer
• Cardiac ablation

Approved in United States as MRgRT for:

• Prostate cancer
• Rectal cancer
• Liver cancer
• Pancreatic cancer
• Lung cancer
• Breast cancer

Approved in Canada as MRgRT for:

• Prostate cancer
• Rectal cancer
• Liver cancer
• Pancreatic cancer
• Lung cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Over 2 years, 316 patients were treated using the world's first MR-IGRT system, which enhances soft tissue visualization and allows for adaptive radiation therapy (ART) and cine gating, improving treatment precision.

The MR-IGRT system has been successfully integrated into a high-volume clinic, demonstrating its efficacy across various cancer types, including abdominal, breast, and pelvic cancers, with ongoing clinical trials planned to further evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. Fischer-Valuck, BW., Henke, L., Green, O., et al.[2022]

In a study of 425 localized prostate cancer patients treated with MR-guided ultrahypofractionated radiation therapy, significant declines in prostate-specific antigen levels were observed, indicating effective treatment outcomes over 12 months.

While the therapy was generally safe, with peak toxicity reported at 3 months, patients not receiving androgen deprivation therapy experienced significant worsening of erectile function by 12 months, highlighting the need for patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Adaptive Radiation Therapy for Prostate Cancer: The First Results from the MOMENTUM study-An International Registry for the Evidence-Based Introduction of Magnetic Resonance-Guided Adaptive Radiation Therapy. Teunissen, FR., Willigenburg, T., Tree, AC., et al.[2023]

The development of an online Magnetic Resonance guided Radiation Therapy (MRgRT) system aims to enhance safety by providing real-time MRI images before radiation treatment, allowing for better image guidance.

A thorough failure modes and effects analysis identified potential risks during the design and operation of the MRgRT system, leading to design improvements and safety measures before installation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poster - Thur Eve - 05: Safety systems and failure modes and effects analysis for a magnetic resonance image guided radiation therapy system. Lamey, M., Carlone, M., Alasti, H., et al.[2019]

Magnetic resonance-guided radiation therapy (MRgRT) has been successfully implemented in treating localized prostate cancer for 140 patients, allowing for daily plan re-optimization and improved targeting during treatment delivery.

Patient feedback indicated that MRgRT was generally well tolerated, although the treatment sessions were longer (averaging 45 minutes) and some patients reported discomfort from noise during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implementation of magnetic resonance imaging guided adaptive radiotherapy for localized prostate cancer. Tetar, SU., Bruynzeel, AME., Lagerwaard, FJ., et al.[2022]

Magnetic resonance-guided radiation therapy (MRgRT) provides superior soft tissue contrast compared to conventional CT-based methods, enhancing the visualization of tumors and surrounding healthy tissues in abdominal and thoracic cancers.

The use of MRgRT allows for high-precision localization of tumors through real-time tracking and adaptive capabilities, improving treatment accuracy for difficult-to-visualize targets like those in the lung, kidney, liver, and stomach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Era of Image Guidance with Magnetic Resonance-guided Radiation Therapy for Abdominal and Thoracic Malignancies. Mittauer, K., Paliwal, B., Hill, P., et al.[2022]

A survey of 12 pediatric radiotherapy institutions indicated that while the expected benefit of magnetic resonance guided radiotherapy (MRgRT) for reducing toxicity and improving outcomes is modest, there is a significant potential for benefit in 55% of primary tumor scenarios and 62% of metastatic tumor scenarios.

The study highlights the need for further investigation into MRgRT's role in pediatric oncology, particularly through prospective studies or registration trials, to better understand its impact on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of MR-guided adaptive radiotherapy in pediatric oncology: Results from a SIOPE-COG survey. Seravalli, E., Kroon, PS., Buatti, JM., et al.[2022]

A dedicated MR-guided radiotherapy (MRgRT) facility has been developed to enhance the integration of magnetic resonance imaging into the radiotherapy treatment process, improving confidence in dose placement.

This facility combines advanced imaging and treatment technologies, allowing for real-time treatment guidance and adaptive replanning, which can lead to safer and more effective cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A facility for magnetic resonance-guided radiation therapy. Jaffray, DA., Carlone, MC., Milosevic, MF., et al.[2022]

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]

In a study of 69 prostate cancer patients treated with MR-guided radiation therapy, 24.6% experienced acute grade 2 genitourinary (GU) toxicity, highlighting the need for improved dosimetric predictors to minimize this side effect.

The study identified key dosimetric features, particularly related to bladder and trigone doses, that can predict GU toxicity, with the best prediction model achieving an accuracy of 79%, suggesting that careful monitoring of these doses could enhance treatment planning and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric predictors for genitourinary toxicity in MR-guided stereotactic body radiation therapy (SBRT): Substructure with fraction-wise analysis. Pham, J., Neilsen, BK., Liu, H., et al.[2023]

Magnetic Resonance-guided Radiation Therapy (MRgRT) shows promise for safely delivering high doses of radiation to oligometastatic tumors while protecting surrounding healthy tissues, thanks to its superior imaging capabilities and real-time monitoring.

Despite its potential, further clinical evidence is needed to address technical challenges and ensure safety in the MRI environment, highlighting the importance of ongoing research in this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Radiotherapy (MRgRT) for Treatment of Oligometastases: Review of Clinical Applications and Challenges. Chetty, IJ., Doemer, AJ., Dolan, JL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11763864/

Evolving Trends and Patterns of Utilization of Magnetic ... This single-institution retrospective analysis evaluated patients treated with MRgRT on a 0.35-T MRIdian-Linac between April 2018 and April 2024.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879850022003630

Magnetic Resonance-Guided Adaptive Radiation Therapy ... Conclusions. The results presented in the current study show that the treatment of localized PCa with SBRT on a 1.5T MR-Linac is effective and safe.

3. redjournal.org redjournal.org/article/S0360-3016(24)00691-6/fulltext

Patient-Reported Outcomes Following Magnetic ... In conclusion, PROs of patients with prostate cancer treated with MRgRT show a relevant temporary deterioration in the urinary and bowel domain ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36462619/

Magnetic Resonance-Guided Adaptive Radiotherapy for ... We report the 12-month outcomes for the first PCa patients treated within an international consortium ([XXXX] study) on a 1.5T MR-Linac system with ultra- ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818117

Safety and Tolerability of Online Adaptive High-Field ... The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38691356/

Safety and Tolerability of Online Adaptive High-Field Magnetic ... In this cohort study of patients treated on a 1.5-T MR-Linac, radiotherapy was safe and well tolerated.