MRI Scans During Radiation Therapy for Cancer

(RELAY Trial)

Recruiting at 1 trial location

Overseen By Jonathan Leeman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Allergy to gadolinium, MRI inability, 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: 3

139 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma. The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma. The research study procedures include: * Screening for eligibility * Three MRI scans

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 MRI scans during radiation therapy for cancer?

Research shows that MRI scans can significantly improve radiation therapy planning by providing detailed images of tumors, which led to changes in treatment plans in 53% of cases and increased confidence in 33% of cases. MRI-guided radiation therapy is emerging as a promising approach due to its ability to offer better soft-tissue contrast and monitor changes during treatment, potentially leading to more precise and effective cancer treatment. ^{1 2 3 4 5}

Is MRI safe to use during radiation therapy for cancer?

MRI safety is a key concern when used during radiation therapy, especially since many patients have implants or devices that may not be clearly labeled for MRI safety. Radiation therapy staff need specific training to work safely with MRI equipment, and special safety programs are being developed to address these needs. ^{6 7 8 9 10}

How does MRI-guided radiation therapy differ from other cancer treatments?

MRI-guided radiation therapy is unique because it uses MRI during treatment to provide better soft-tissue contrast and real-time adaptation to changes in the tumor and surrounding organs, unlike traditional CT-guided radiation therapy. This allows for more precise targeting of the cancer while minimizing damage to healthy tissue. ^{2 11 12 13 14}

Research Team

Jonathan Leeman, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric high-grade glioma who need radiation therapy. They must be in a condition to understand and sign consent. Exclusions include allergies to MRI contrast (unless not using contrast) and inability to undergo MRI.

Inclusion Criteria

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

I am 18 or younger, or up to 30 if my doctor agrees, with a severe brain tumor and will have radiation therapy.

My cancer needs radiation treatment.

Exclusion Criteria

I don't need contrast for my treatment, so my kidney function doesn't matter.

Disease-specific exclusion criteria will be specified in a sub protocol.

For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Radiation Therapy

Participants undergo standard of care radiation therapy with MRI scans before, during, and after treatment

Varies by disease site standards

3 MRI scans (1 before, 1 during, 1 after radiation therapy)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Optional Expansion Cohort

Participants may opt into an imaging registry evaluating imaging biomarkers as predictors of disease control

2 years

Treatment Details

Interventions

• MRI Imaging

Trial Overview The study tests the use of serial MRIs—before, during, and after standard radiation therapy—to monitor treatment response in patients with certain advanced cancers. It's a phase 1 trial focused on feasibility and utility of this imaging technique during treatment.

Participant Groups

Group I: Vulvar Cancer Cohort Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Group II: Prostate Cancer Expansion Cohort Serial MR Imaging Registry Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. * Genomic testing of biopsy sample

Group III: Prostate Cancer Cohort Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. * Genomic testing of biopsy sample

Group IV: Pediatric Glioma Cohort Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Group V: Glioblastoma Expansion Cohort Serial MR Imaging Registry Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Group VI: Glioblastoma Cohort Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Group VII: Esophageal Cohort Experimental Treatment 1 Intervention

The research study procedures include: * Screening for eligibility * Three MRI scans (prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

The study evaluated breast MRI image quality across three different radiotherapy positions: prone, supine flat, and supine inclined, focusing on their effectiveness for radiotherapy planning.

Results indicated that supine breast MRI provides image quality comparable to prone breast MRI, making it a viable option for radiotherapy delineation using T2-weighted sequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of MRI image quality for various setup positions used in breast radiotherapy planning. Batumalai, V., Liney, G., Delaney, GP., et al.[2018]

MRI-guided radiation therapy (RT) offers significant advantages over traditional CT-based methods, including better soft-tissue contrast and the ability to visualize organ motion, which can enhance treatment planning and monitoring.

Emerging technologies in MRI-guided RT, such as real-time adaptive treatment and MRI-derived biomarkers, have the potential to improve cancer treatment by allowing for adjustments based on physiological changes during therapy, although challenges like image distortion and the need for standardized imaging protocols remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Radiation Therapy: An Emerging Paradigm in Adaptive Radiation Oncology. Otazo, R., Lambin, P., Pignol, JP., et al.[2022]

The 0.55 T low-field MRI scanner demonstrated high geometric accuracy and image quality suitable for radiotherapy treatment planning, with a minimal geometric distortion of 1.2 mm after correction.

In a comparison of metastasis detection between low-field and high-field MRI, no significant differences were found, indicating that the low-field MRI can effectively identify brain metastases similarly to higher-field systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of magnetic resonance images acquired at a novel low-field 0.55 T scanner for brain radiotherapy treatment planning. Grigo, J., Masitho, S., Fautz, HP., et al.[2023]

In a study of 30 patients undergoing radiation therapy, magnetic resonance (MR) imaging significantly altered the treatment plan in 53% of cases, highlighting its importance in accurately defining tumor extent and margins.

Additionally, MR imaging increased the confidence in the original radiation therapy plans for 33% of the patients, suggesting that incorporating MR could enhance the overall effectiveness of radiation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging in radiation therapy planning. Work in progress. Shuman, WP., Griffin, BR., Haynor, DR., et al.[2015]

In a study of 80 cervical cancer patients, tumor volume and regression ratios measured through MRI during radiation therapy were found to be strong predictors of local recurrence and death from disease, with significant correlations observed at various stages of treatment.

Algorithms combining these tumor metrics improved predictive accuracy, with the best results showing 89% sensitivity and 87% specificity for predicting local recurrence, indicating that early monitoring can help identify patients at higher risk for poor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential magnetic resonance imaging of cervical cancer: the predictive value of absolute tumor volume and regression ratio measured before, during, and after radiation therapy. Wang, JZ., Mayr, NA., Zhang, D., et al.[2022]

The integration of MRI into radiation oncology has raised important safety considerations, especially for patients with prior surgeries and implanted devices, necessitating tailored safety protocols.

This report outlines a specialized MR safety program specifically designed for radiation oncology departments, addressing their unique requirements compared to traditional radiology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Magnetic Resonance Safety Program for Radiation Oncology. Gach, HM., Green, OL., Mackey, SL., et al.[2023]

The study successfully implemented a post-contrast 3D T1-weighted and dynamic contrast enhancement protocol using a 0.35T MRI-Linac, demonstrating its feasibility for assessing glioblastoma response to radiotherapy.

Results showed that the 3D T1 contrast enhancement volumes were comparable to those obtained from a 3T scanner, and Ktrans values indicated significant differences in treatment response, with responders showing a 54% decrease in Ktrans compared to an 8.6% increase in non-responders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a dynamic contrast enhanced MR perfusion protocol for glioblastoma using a 0.35T MRI-Linac system. Maziero, D., Azzam, G., de La Fuente, M., et al.[2023]

The study evaluated two quality assurance (QA) protocols for MRI in radiotherapy, finding that the ACR MRI QA phantom effectively detected common issues affecting image quality, such as signal variations and electric interference.

Combining the ACR phantom with a commercial geometric accuracy phantom showed promise in monitoring MRI system performance, although the ACR protocol struggled to identify individual coil element failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity analysis of different quality assurance methods for magnetic resonance imaging in radiotherapy. Adjeiwaah, M., Garpebring, A., Nyholm, T.[2022]

Integrating MRI into radiation therapy offers significant benefits, such as real-time imaging for tracking patient movement without ionizing radiation, but poses unique safety challenges that need to be addressed for effective clinical implementation.

Many radiation therapy staff lack experience in MRI environments, and there is a need for specific MR safety protocols and testing for devices used in radiation therapy, as existing safety labels may not be clear or applicable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Safety Considerations for Integration of Magnetic Resonance Imaging in Radiation Therapy. Hu, Q., Yu, VY., Yang, Y., et al.[2021]

MRI-guided radiation therapy (RT) is revolutionizing cancer treatment by improving precision in target identification and treatment delivery, which enhances the overall effectiveness of cancer care.

This innovative approach not only transforms clinical workflows and quality assurance in RT but also opens up new research opportunities in oncology, indicating a significant shift in how radiation therapy may be conducted in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The transformation of radiation oncology using real-time magnetic resonance guidance: A review. Hall, WA., Paulson, ES., van der Heide, UA., et al.[2022]

Magnetic resonance imaging (MR) is becoming increasingly important in radiation oncology for planning and delivering radiotherapy, enhancing the precision of treatment.

The review highlights both the advantages and challenges of integrating MR technology with radiation therapy, including the need for specialized equipment and systems to accurately estimate electron density from MR images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance image guidance in external beam radiation therapy planning and delivery. Arivarasan, I., Anuradha, C., Subramanian, S., et al.[2018]

Magnetic resonance imaging (MR) is increasingly used in radiation oncology due to its superior soft-tissue contrast and ability to provide functional information, enhancing treatment accuracy.

In-room MR imaging systems allow for real-time visualization of treatment targets and surrounding organs, improving target localization and enabling adaptive treatment plans during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging for Target Delineation and Daily Treatment Modification. Kashani, R., Olsen, JR.[2018]

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]

The hybrid 0.35T MRI and radiation therapy system enhances treatment planning for spinal metastases by providing clearer images that reduce artifacts from spinal hardware, improving the accuracy of target delineation.

This system allows for adaptive radiation therapy, which can adjust treatment in real-time to protect nearby organs at risk, making it a safer option for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of Radiation Therapy Simulation with 0.35 Tesla Magnetic Resonance Imaging for Stereotactic Ablation of Spinal Metastases. Spieler, B., Samuels, SE., Llorente, R., et al.[2021]

References

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

Assessment of MRI image quality for various setup positions used in breast radiotherapy planning. [2018]

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

MRI-guided Radiation Therapy: An Emerging Paradigm in Adaptive Radiation Oncology. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Usability of magnetic resonance images acquired at a novel low-field 0.55 T scanner for brain radiotherapy treatment planning. [2023]

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

MR imaging in radiation therapy planning. Work in progress. [2015]

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

Sequential magnetic resonance imaging of cervical cancer: the predictive value of absolute tumor volume and regression ratio measured before, during, and after radiation therapy. [2022]

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

Implementation of Magnetic Resonance Safety Program for Radiation Oncology. [2023]

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

Implementation and evaluation of a dynamic contrast enhanced MR perfusion protocol for glioblastoma using a 0.35T MRI-Linac system. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Sensitivity analysis of different quality assurance methods for magnetic resonance imaging in radiotherapy. [2022]

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

Practical Safety Considerations for Integration of Magnetic Resonance Imaging in Radiation Therapy. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The transformation of radiation oncology using real-time magnetic resonance guidance: A review. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Magnetic resonance image guidance in external beam radiation therapy planning and delivery. [2018]

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

Magnetic Resonance Imaging for Target Delineation and Daily Treatment Modification. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Advantages of Radiation Therapy Simulation with 0.35 Tesla Magnetic Resonance Imaging for Stereotactic Ablation of Spinal Metastases. [2021]