MR-Guided Radiotherapy for Cancer

Overseen By Nawaid Usmani, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Mri contraindications, Pregnancy, others

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

Duration: Approximately 26 months

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of guiding radiotherapy for cancer using MRI scans instead of the usual CT scans. The goal is to determine if this approach better targets cancer and reduces side effects. It is specifically for individuals who can undergo radiation therapy and are comfortable with MRI scans. Participants will help researchers assess the effectiveness of this new technology, known as MR-guided radiotherapy (MRgRT), and whether it meets the needs of both doctors and patients. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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 Linac-MR is safe for cancer treatment?

Research has shown that MR-guided radiotherapy is generally safe. Studies have found a low risk of serious side effects with this treatment. In one study, patients experienced few severe immediate side effects, indicating these were uncommon and that patients tolerated the treatment well. Additionally, MR-guided radiotherapy has been tested in various situations, such as prostate cancer, with similarly low side effects. Although this trial remains in the early stages, existing evidence suggests that MR-guided radiotherapy is quite safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MR-guided radiotherapy for cancer because it offers a more precise and targeted approach compared to traditional radiotherapy methods. Unlike standard options, which often rely on CT scans for imaging, this treatment uses real-time MRI to guide the radiation, allowing for better accuracy in targeting tumors while sparing healthy tissues. This precision could lead to fewer side effects and improved outcomes for patients. Additionally, the ability to adjust treatment in real-time based on tumor response is a significant advancement, potentially improving the effectiveness of radiotherapy for both curative and palliative purposes.

What evidence suggests that MR guided radiotherapy is effective for cancer?

Research has shown that using MRI to guide radiotherapy holds promise for cancer treatment. In this trial, participants will receive MR-guided radiotherapy using the Alberta linac-MR P3 system. One study with over 350 radiation sessions found that nearly all treatments proceeded as planned, with only a few cases of serious side effects. Another study examining long-term results found early positive signs, such as lower cancer markers, with mostly short-term side effects. Overall, this method appears to have a lower risk of serious side effects while effectively targeting cancer. These findings suggest that MRI-guided radiotherapy could make cancer treatment more precise and safer. ^{1 2 4 6 7}

Who Is on the Research Team?

Nawaid Usmani, MD

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can undergo external beam radiation therapy and are available for follow-up. It's not suitable for those unable to lie still during scans, cannot consent, have inferior treatment plans with this method compared to standard CT, are pregnant, or have MRI contraindications.

Inclusion Criteria

Accessible for follow-up

My radiation oncologist says I'm fit for external beam radiation therapy.

Exclusion Criteria

I am unable to understand or sign the consent form.

Patients with contraindications for MRI

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MR-guided radiotherapy using the Alberta linac-MR P3 system in four graduated stages, progressing from palliative to curative treatments.

Approximately 26 months

Weekly visits for radiotherapy sessions

Follow-up

Participants are monitored for adverse events and treatment effectiveness at 1, 3, 6, and 12 months following completion of radiotherapy, with annual assessments for up to 5 years.

Up to 5 years

Annual visits (in-person or via chart review)

What Are the Treatments Tested in This Trial?

Interventions

• MR guided radiotherapy

Trial Overview The Northern LIGHTs-2 study tests a new MR guided radiotherapy technology called Linac-MR. This Phase I/II trial aims to check if the treatment can be completed as planned and assess its effects on cancer and any potential radiation side effects.

How Is the Trial Designed?

Group I: MR guided radiotherapy Experimental Treatment 1 Intervention

MR-guided radiotherapy using the Alberta linac-MR P3 system. Contemporary radiotherapy techniques and fractionation schedules will be conducted in the following graduated stages with overlap between stages allowed: Stage 1: Parallel-opposed pair treatments (palliative) Stage 2: 4 field box treatments (curative or palliative) Stage 3: High dose treatments - multi-field 3DCRT (curative or palliative) Stage 4: High dose treatments - multi-field IMRT (curative or palliative)

MR guided radiotherapy is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as MRgRT for:

• Prostate cancer
• Rectal cancer
• Breast cancer
• Lung cancer
• Stomach cancer

Approved in European Union as MR-Linac for:

• Prostate cancer
• Rectal cancer

Approved in United States as MRgRT for:

• Prostate cancer
• Rectal cancer

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

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]

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 study successfully demonstrated that high-quality treatment plans for MR-guided radiotherapy (MR-linac) can be created, showing feasibility for clinical use in rectal and prostate cancer patients.

MR-linac plans resulted in slightly higher doses to the target areas compared to conventional plans, but all plans were clinically equivalent to current practices, indicating that MR-linac could be a viable option for improving radiotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of plan quality in radiotherapy planning with an MR-linac. van de Schoot, AJAJ., van den Wollenberg, W., Carbaat, C., et al.[2022]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10579578/

Clinical outcomes after online adaptive MR-guided ... A total of 357 of the 358 fractions from all hypofractionated schemes were delivered as planned. Grade 3–4 acute toxicity occurred in 3 of 59 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000193

MRI-guided radiotherapy in twenty fractions for localised ... We evaluate two-year toxicity outcomes, early biochemical response and patient-reported outcomes (PRO), using data obtained from a multicentre international ...

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. 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07142967

Trial Evaluating the Safety and Efficacy Of MR-Linac ... The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063805/

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.

7. 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.