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: Dana-Farber Cancer Institute

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

Trial Summary

What is the purpose of this trial?

This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation 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 data supports the effectiveness of the treatment MRI-Guided Radiation Therapy for Cancer?

Research shows that image-guided radiotherapy (IGRT), a component of MRI-guided radiation therapy, can precisely target tumors while sparing healthy tissue, potentially reducing side effects and improving outcomes. Additionally, intraoperative radiation therapy (IORT), another component, has been effective in improving local control and survival rates in various cancers, including breast cancer. ^{1 2 3 4 5}

Is MRI-guided radiation therapy generally safe for humans?

Image-guided radiotherapy (IGRT), which includes MRI-guided techniques, is generally considered safe and is associated with fewer acute and chronic side effects compared to some other radiation therapies. However, one study noted a worse overall survival in a specific trial, highlighting the importance of ongoing safety evaluations. ^{4 6 7 8 9}

How is MRI-guided radiation therapy different from other cancer treatments?

MRI-guided radiation therapy is unique because it uses magnetic resonance imaging (MRI) to precisely target tumors while sparing surrounding healthy tissue. This approach allows for real-time tracking and adaptation of the treatment plan based on changes in the tumor's position or size, offering improved accuracy compared to traditional methods. ^{10 11 12 13 14}

Research Team

Raymond Mak, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

I am 18 years old or older.

My cancer needs radiation therapy.

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

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

Treatment Details

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.

Participant Groups

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?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A (short) history of image-guided radiotherapy. [2022]

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

Intraoperative radiation therapy. [2022]

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

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]

4. Germany 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. [2022]

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

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. [2011]

6. England 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. [2021]

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

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. [2022]

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

Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. [2022]

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

A New Era of Image Guidance with Magnetic Resonance-guided Radiation Therapy for Abdominal and Thoracic Malignancies. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Treatment planning with functional MRI]. [2018]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical implementation of magnetic resonance imaging guided adaptive radiotherapy for localized prostate cancer. [2022]