MRI-Guided Radiation Therapy for Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Jonathan Leeman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pregnancy, Severe claustrophobia, MRI intolerance, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. * The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

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 MRI-guided radiation therapy (MRgRT) is feasible and safe for treating certain cancers, like oligometastatic disease, by allowing precise targeting of tumors with minimal damage to surrounding healthy tissue. This approach improves the ability to adapt treatment plans daily based on changes in the patient's anatomy, potentially leading to better outcomes. ^{1 2 3 4 5}

Is MRI-guided radiation therapy generally safe for humans?

MRI-guided radiation therapy (MRgRT) has been used safely in clinical settings for several years, with studies showing it can be delivered without added radiation exposure and is feasible for safe treatment of certain conditions. ^{2 4 6 7 8}

What makes MRI-Guided Radiation Therapy unique compared to other cancer treatments?

MRI-Guided Radiation Therapy is unique because it uses real-time imaging to precisely target tumors, allowing for adjustments during treatment without additional radiation exposure. This approach improves accuracy and adapts to changes in the patient's anatomy, potentially leading to better outcomes. ^{1 4 5 6 9}

Research Team

Jonathan Leeman, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with certain types of cancer, including oral, lung, kidney, prostate cancers and more. Participants must be over 18 years old with tumors ≤7cm that need stereotactic body radiation therapy. They should understand the study and agree to participate by signing a consent form. People who are pregnant or have severe claustrophobia/anxiety or allergies to MRI contrast agents (unless not receiving contrast) cannot join.

Inclusion Criteria

Age 18 years of older

Tumor size ≤ 7cm

Confirmed malignancy requiring stereotactic body radiation therapy

Exclusion Criteria

History of allergic reactions attributed to gadolinium-based IV contrast (Note: If a patient will not receive contrast, this is not applicable)

The exclusion criteria for each group of participants with the same disease will be explained separately.

Women who are currently pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Feasibility and Safety Evaluation

Evaluate the feasibility and safety of delivering SMART in patients with cancer

1 year

Multiple visits for MR-guided treatment and monitoring

Phase 2: Efficacy Evaluation

Evaluate efficacy of SMART with specific reference to tumor control and improvement in patient-reported outcome measures

1 year

Multiple visits for MR-guided treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits to assess long-term toxicity and survival rates

Treatment Details

Interventions

• Stereotactic Magnetic Resonance Guided Radiation Therapy (Radiation Therapy)

Trial Overview The trial is testing Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART). Phase I checks if SMART can be safely given to patients with cancer while Phase II looks at how well it controls tumors and improves patient-reported outcomes.

Participant Groups

Group I: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group II: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group III: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group IV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group V: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group VI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group VII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group VIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group IX: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group X: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XIV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XVI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XVII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XVIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Group XIX: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis Experimental Treatment 1 Intervention

SMART will be administered per each individual disease site standards

Stereotactic Magnetic Resonance Guided Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as MRgRT for:

• Prostate cancer
• Liver cancer
• Rectal cancer
• Pancreatic cancer
• Lymph node cancer
• Breast cancer
• Head and neck cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Findings from Research

The first clinical implementation of online adaptive magnetic resonance image-guided radiation therapy (MR-IGRT) was successfully conducted on 5 patients with abdominopelvic cancers, demonstrating the feasibility of real-time adaptive planning during treatment.

Out of 170 treatment fractions in an expanded cohort, 30.6% required online reoptimization, indicating that adapting treatment plans based on daily imaging can effectively address changes in tumor size and patient anatomy, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Acharya, S., Fischer-Valuck, BW., Kashani, R., et al.[2022]

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]

In a phase 1 trial involving 22 prostate cancer patients, stereotactic MR-guided adaptive radiation therapy (SMART) demonstrated a low risk of acute urinary (22.7%) and gastrointestinal (4.5%) toxic effects, with no severe grade 3+ events reported.

Daily plan adaptation during SMART significantly improved dosimetry, ensuring that 100% of treatment plans were optimized to protect critical organs, highlighting the importance of real-time adjustments in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Prostate Stereotactic Body Radiation Therapy With Daily Online Plan Adaptation: Results of a Prospective Phase 1 Trial and Supplemental Cohort. Leeman, JE., Cagney, DN., Mak, RH., et al.[2022]

MRI-guided radiotherapy (MRIgRT) has been effectively used in treating 642 patients over 4.5 years, with breast and gastrointestinal cancers being the most common indications, showcasing its broad applicability in radiation oncology.

Adaptive radiotherapy (ART) was utilized in 190 patients, with a significant 67.6% of treatment fractions being adapted, particularly for abdominal cancers, indicating the technology's ability to adjust treatment based on real-time anatomical changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. Henke, LE., Contreras, JA., Green, OL., et al.[2023]

Magnetic resonance imaging (MRI)-guided adaptive radiotherapy enhances the precision of radiation treatment by providing real-time anatomical and functional imaging during therapy sessions.

This advanced imaging technique could lead to improved treatment outcomes by allowing for adjustments in radiation delivery based on the patient's changing anatomy throughout the course of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided adaptive radiotherapy: a solution to the future. Kupelian, P., Sonke, JJ.[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]

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]

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]

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]

References

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

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. [2022]

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

MRI-guided Radiotherapy (MRgRT) for Treatment of Oligometastases: Review of Clinical Applications and Challenges. [2022]

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

Magnetic Resonance-Guided Prostate Stereotactic Body Radiation Therapy With Daily Online Plan Adaptation: Results of a Prospective Phase 1 Trial and Supplemental Cohort. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. [2023]

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

Magnetic resonance-guided adaptive radiotherapy: a solution to the future. [2022]

6. 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]

7. United States 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. [2019]

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

A facility for magnetic resonance-guided radiation therapy. [2022]

9. United States 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. [2023]