MRI-Guided Radiation Therapy for Cancer

(JUMP 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, MRI incompatibility, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how MRI, a scan using magnets and radio waves to create images, can aid in planning radiation therapy for cancer. The goal is to determine if MRI can improve the accuracy of targeting tumors with radiation, potentially enhancing treatment effectiveness. The trial includes different groups to test various methods of using MRI in treatment planning. Individuals with cancer who require radiation therapy might be suitable for this trial, especially if they can undergo an MRI scan. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance future 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 MRI-guided radiation therapy is safe?

Research has shown that online adaptive MR-guided radiotherapy, a type of radiation treatment, carries a low risk of serious side effects. Studies indicate that most patients tolerate this treatment well, with a very low chance of severe short-term side effects. Using MRI to guide and plan radiation treatments is generally safe for most people. While all treatments carry some risks, evidence suggests this method is quite safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided radiation therapy for cancer because it offers a more precise way to target tumors. Unlike traditional radiation therapy, which relies on CT scans, this method uses MRI imaging for better accuracy in mapping the tumor. This precision allows doctors to tailor the radiation dose more effectively, potentially leading to fewer side effects and better outcomes. Additionally, the ability to adjust treatment plans based on high-resolution MRI data means that therapy can be more adaptive to changes in the tumor, which could improve overall effectiveness.

What evidence suggests that MRI-guided radiation therapy could be effective for cancer?

Studies have shown that radiation therapy plays a crucial role in cancer treatment, with about half of all cancer patients receiving it. Some research indicates that it successfully controls cancer in 96% of cases and achieves a 92% survival rate after two years. In this trial, participants will be assigned to different arms involving MRI simulators. These simulators help doctors target cancer more accurately by providing clear images, leading to better treatment planning and potentially improved patient outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Raymond Mak, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain cancers (like prostate, liver, and head & neck) who need radiation therapy. They should be relatively active (able to care for themselves), able to consent, and meet specific criteria listed in subprotocols. People can't join if they have allergies to MRI contrast agents or can't undergo an MRI.

Inclusion Criteria

My cancer needs radiation therapy.

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

I can take care of myself but might not be able to do active work.

Exclusion Criteria

For MRI involving contrast, history of allergic reactions attributed to gadoliniumbased IV contrast. Note: If patient will not receive contrast, this is not applicable

Disease-specific exclusion criteria will be specified in the appropriate subprotocol

You are unable to have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Feasibility Study

Determine the feasibility of using an MRI simulator to plan radiation therapy

1 year

Multiple visits for MRI data acquisition and radiation planning

Phase II: Efficacy Study

Evaluate the efficacy of adjusting radiation therapy based on MRI simulation

24 months

Regular visits for MRI simulation and radiation therapy adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• MRI Simulator
• Radiation Therapy

Trial Overview The study is testing the use of MRI simulation alongside standard radiation therapy in treating cancer. It's a two-phase study aiming to see how well this combination works and how feasible it is as a treatment planning method.

How Is the Trial Designed?

Group I: Phase II MR Simulation Protocol: Track B Experimental Treatment 2 Interventions

Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)

Group II: Phase II MR Simulation Protocol: Track A Experimental Treatment 2 Interventions

MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment

Group III: Phase I MRI Simulation Experimental Treatment 2 Interventions

This research study involves a screening period to determine eligibility. \- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

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

MRI-guided radiotherapy enables real-time adjustments to radiation plans based on changes in patient anatomy and function during treatment, enhancing treatment precision.

This innovative approach has the potential to improve outcomes for patients with various urological cancers by expanding the therapeutic window, allowing for more effective and safer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. Kerkmeijer, LGW., Kishan, AU., Tree, AC.[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]

Patients with high-risk prostate cancer treated with image-guided intensity-modulated radiotherapy (IG-IMRT) experienced significantly lower rates of gastrointestinal (GI) toxicity (5.8%) compared to those treated with 3D conformal radiotherapy (3DCRT) (57.3%), indicating that IG-IMRT is a safer option.

Both IG-IMRT and 3DCRT showed similar rates of biochemical progression-free survival at 3 years (90.3% for IG-IMRT vs. 86.0% for 3DCRT), suggesting that while IG-IMRT reduces toxicity, it does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

Prostate cancer patients receiving image-guided radiotherapy (IGRT) experienced significantly less severe acute toxicity, such as urinary frequency, diarrhoea, and fatigue, compared to those who did not receive IGRT, with 23% vs 7% for urinary frequency ≥G3 and 15% vs 3% for diarrhoea ≥G2.

The onset of these toxicities was earlier in the non-IGRT group, indicating that IGRT not only reduces the severity of symptoms but also delays their onset, leading to a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. Gill, S., Thomas, J., Fox, C., et al.[2021]

Intraoperative radiation therapy (IORT) allows for targeted radiation delivery during surgery, which can enhance local control of tumors while minimizing damage to surrounding healthy tissues, making it particularly beneficial for patients with locally advanced or recurrent cancers.

The addition of IORT to standard treatment regimens has shown improved local control and survival rates in various cancers, including rectal cancer and breast cancer, suggesting its potential for broader application in clinical practice as new, cost-effective devices become available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy. Willett, CG., Czito, BG., Tyler, DS.[2022]

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

In a study of 58 patients receiving high-dose radiation therapy for prostate cancer, using gold markers for image-guided radiation therapy (IGRT) reduced residual positioning errors, particularly in the vertical direction.

Despite the reduction in positioning errors with gold markers, the overall differences in dose distributions were moderate, suggesting that daily megavoltage CT (MVCT) alone could be a sufficient and valid alternative for IGRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. Wust, P., Joswig, M., Graf, R., et al.[2022]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 836 prostate cancer patients, those who received image-guided radiotherapy (IGRT) had a 5-year overall survival rate of 88%, which was not significantly different from the 86% survival rate of patients who did not receive IGRT, indicating that IGRT does not negatively impact survival outcomes.

The study found no significant differences in mortality rates from prostate cancer, other cancers, or cardiovascular issues between the IGRT and non-IGRT groups, suggesting that IGRT is a safe option for localized prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. Kuo, YH., Liang, JA., Chen, GH., et al.[2022]

Magnetic resonance imaging (MRI) guided radiotherapy allows for high precision in targeting tumors while sparing surrounding healthy tissue, which is crucial for effective treatment delivery.

The innovative approach of 'dose painting' enables tailored irradiation based on the biological behavior of tumors, potentially improving local control and reducing the risk of recurrence by addressing areas that are more resistant to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment planning with functional MRI]. Georg, P., Andrzejewski, P., Pinker, K., et al.[2018]

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]

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]

Image-guided radiation therapy (IGRT) enhances the precision of radiotherapy by allowing real-time imaging to adjust radiation delivery based on the exact location and changes in tumor size during treatment.

Recent advancements in IT infrastructure and irradiation techniques have revitalized interest in IGRT, highlighting that many previous innovations were not fully integrated into standard practice, which could improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A (short) history of image-guided radiotherapy. Verellen, D., De Ridder, M., Storme, G.[2022]

In a study of 22 patients with locally advanced rectal cancer, image-guided radiotherapy (IGRT) led to complete surgical resection in all cases, with 32% of patients showing no residual tumor after treatment.

The treatment was associated with minimal toxicity, although one patient experienced severe side effects likely due to an overdose of capecitabine, suggesting that IGRT is a promising approach for reducing complications in rectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. Nguyen, NP., Ceizyk, M., Almeida, F., et al.[2011]

Citations

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Practice MRI scanning on your laptop The Corsmed MRI Simulator offers unlimited hands-on training in MRI, accessible from any laptop, anytime, anywhere.

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