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

149 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if MRI scans (Magnetic Resonance Imaging) can effectively monitor the progress of radiation therapy for certain cancers, such as advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer, and pediatric glioma. Participants will undergo three MRI scans: one before starting radiation, one midway through, and one after completing the treatment. This study suits individuals with these specific cancers who are about to begin radiation therapy and wish to assist researchers in finding better ways to track treatment progress. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future cancer treatment monitoring.

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 scans are safe during radiation therapy for cancer?

Research has shown that MRI scans are generally safe for most people. Unlike X-rays or CT scans, MRIs do not use ionizing radiation, eliminating the risk of radiation exposure. This is reassuring for those who need multiple scans.

Studies indicate that MRI safety primarily involves ensuring no metal is in or on the body. Metal can pose a problem because MRIs use strong magnets that might move or heat metal objects. Therefore, everyone is checked for metal before the scan.

Reports of safety problems with MRIs are very few. Incidents are rare and usually occur when safety guidelines, such as removing metal jewelry, are not followed.

In summary, MRIs are well-tolerated and generally safe. They are a common imaging tool used for various medical purposes without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI scans during radiation therapy for cancer because these scans offer a non-invasive way to closely monitor how tumors respond to treatment in real-time. Unlike standard imaging methods, MRI provides detailed images without radiation exposure, which is particularly beneficial for tracking changes during radiation therapy. By using MRI, doctors can potentially tailor treatments more precisely to each patient's needs, improving outcomes and reducing side effects. This approach could revolutionize how we understand tumor progression and treatment effectiveness, offering a more personalized and safer cancer treatment strategy.

What evidence suggests that MRI imaging is effective for assessing treatment response during radiation therapy for cancer?

This trial will evaluate the use of MRI scans during radiation therapy across various cancer cohorts, including sarcoma, esophageal, glioblastoma, vulvar, and prostate cancers. Studies have shown that MRI scans during radiation therapy are promising because they provide clearer images of soft tissues. This clarity allows doctors to see the cancer more distinctly and monitor changes during treatment. Research indicates that combining MRI with radiation therapy helps doctors assess treatment effectiveness. For example, MRI can reveal if the tumor is shrinking or changing in response to radiation. Although the main goal is to determine the usefulness of these scans, early findings suggest they offer valuable insights into treatment progress. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Leeman, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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: Sarcoma 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 III: 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 IV: 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 V: 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 VI: 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 VII: 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 VIII: 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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

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]

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]

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 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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04188535/serial-mri-scans-during-radiation-therapy

Serial MRI Scans During Radiation Therapy This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985133/

Recent innovations in offline and online Magnetic ... The integration of Magnetic Resonance Imaging (MRI) into the field of radiation oncology has significantly influenced the approach to cancer treatment.

3. cancer.gov cancer.gov/clinicaltrials/NCI-2020-02181

Repeated Magnetic Resonance Imaging Scans for the ... This phase I trial studies the feasibility of using repeated magnetic resonance imaging (MRI) scans to analyze cancer response during radiation therapy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04188535

NCT04188535 | Serial MRI Scans During Radiation Therapy 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 ...

5. withpower.com withpower.com/trial/phase-vulvar-neoplasms-2020-626ac

MRI Scans During Radiation Therapy for Cancer 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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8472473/

Practical Safety Considerations for Integration of Magnetic ... Another advantage of MRI is that it does not subject patients to ionizing radiation, which is ideal for continuous real-time imaging for tumor and organ motion ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405632423000288

Incidental findings and safety events from magnetic ... This study retrospectively reviews the incidental findings and safety events that were observed at a single institution during introduction of MRI sim for head ...

8. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/magnetic-resonance-imaging-mri

Magnetic Resonance Imaging (MRI) Because ionizing radiation is not used, there is no risk of exposure to radiation during an MRI procedure. Newer uses for MRI have contributed to the ...

9. mayoclinic.org mayoclinic.org/tests-procedures/mri/about/pac-20384768

MRI Because MRI uses powerful magnets, the presence of metal in your body can be a safety hazard if attracted to the magnet. Even if not attracted ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551669/

Magnetic Resonance Imaging Contraindications - NCBI - NIH All patients must complete a thorough safety screening before undergoing an MRI scan due to potential safety risks. The screening process ...