Spinal Radiosurgery with MR-LINAC for Spinal Diseases

Overseen By Debra N. Yeboa, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Lymphoma, Multiple myeloma, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance spinal radiation therapy using advanced imaging technology called MR-LINAC (Magnetic Resonance Imaging with a Linear Accelerator). The researchers aim to determine if combining this technology with spinal stereotactic radiosurgery (targeted radiation treatment) can improve patient response and quality of life. Participants will be divided into two groups: one receiving treatment on the MR-LINAC machine, and the other receiving standard treatment with additional imaging on the same machine. Individuals diagnosed with cancer affecting up to three spinal vertebrae and maintaining good motor strength in the affected area may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 MR-LINAC and spine radiosurgery are safe for spinal diseases?

Research has shown that spinal radiosurgery using MR-LINAC is generally well-tolerated. MR-LINAC combines MRI scanning with precise radiation therapy, targeting the treatment area more accurately and potentially reducing side effects.

Previous studies suggest that MR-LINAC effectively controls spine-related disease and relieves symptoms, such as pain from cancer that has spread to the spine. While information on serious side effects remains limited, early results indicate that patients handle the treatment well without major issues.

Since this trial is still in the early stages, more research is necessary to confirm these findings. However, the precision of this technology suggests it could be a safer option compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about spinal radiosurgery with MR-LINAC for spinal diseases because it combines precise radiation delivery with advanced imaging. Unlike traditional radiation therapy, the MR-LINAC machine allows doctors to visualize the tumor in real-time while delivering radiation, ensuring that healthy tissues are spared as much as possible. This technology provides a more targeted and potentially more effective treatment by adjusting the radiation delivery based on the tumor's position during the procedure. Additionally, the ability to see immediate changes can lead to faster and more personalized treatment adjustments, offering hope for improved outcomes.

What evidence suggests that MR-LINAC is effective for spinal diseases?

Research has shown that MR-LINAC, a technology combining MRI scans with radiation therapy, provides clear images of the spinal cord and tumors. This precision allows doctors to target treatment more accurately, potentially leading to better results and improved quality of life. In this trial, participants in Group 1 will receive spine radiosurgery on the MR-LINAC machine, which may enhance treatment effectiveness.

Standard spine radiosurgery, which participants in Group 2 will receive using a standard radiation therapy machine, has controlled cancer in the spine well, with complete response rates between 46% and 92%. It effectively treats cancer that has spread to the spine, although some patients may experience fractures in the spine bones. Both treatments aim to manage spinal diseases effectively, with MR-LINAC offering advanced imaging that might improve outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Debra N. Yeboa

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with spinal diseases due to cancer metastasis, affecting up to 3 spine levels. They must be able to undergo MRI with contrast and not have conditions like lymphoma or multiple myeloma that respond well to standard radiation. Pregnant individuals can't participate.

Inclusion Criteria

My cancer diagnosis is officially recorded.

My doctor has approved me for specialized spine radiation therapy.

My spine cancer has spread to no more than 3 connected vertebrae.

Exclusion Criteria

My cancer type is known to respond well to radiation therapy alone.

Patients who are pregnant

Patients who are unable to undergo MRI of the spine with contrast

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal stereotactic radiosurgery (SRSS) using MR LINAC or standard radiation therapy machine

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MR-LINAC
• Spine Radiosurgery

Trial Overview The study tests if advanced imaging (MRI) combined with a Linear Accelerator (MR-LINAC) during Spinal Stereotactic Radiosurgery (SRSS) improves treatment response and quality of life compared to traditional methods.

How Is the Trial Designed?

Group I: Group 2 (Imaging-only Cohort) Experimental Treatment 2 Interventions

Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.

Group II: Group 1 (Therapeutic Cohort) Experimental Treatment 3 Interventions

Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

MR-LINAC is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as MR-LINAC for:

• Spinal metastases
• Primary spinal tumors
• Benign spinal lesions

Approved in United States as MR-LINAC for:

• Spinal metastases
• Primary spinal tumors
• Benign spinal lesions

Approved in Canada as MR-LINAC for:

• Spinal metastases
• Primary spinal tumors
• Benign spinal lesions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The study demonstrated that using the MR-Linac for spine stereotactic body radiation therapy (SBRT) is feasible and can improve cord sparing compared to traditional VMAT techniques, with a maximum dose to the spinal cord showing a trend towards reduction.

Real-time MRI visualization of the spinal cord during treatment may allow for more precise targeting and potentially safer treatment options, enabling adaptive therapy and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. Redler, G., Stevens, T., Cammin, J., et al.[2020]

MRI-guided radiotherapy (MRI-RT) for spinal metastases is feasible using Co-60 technology, with successful treatment delivery and no observed toxicities in nine cases.

Switching to newer linear accelerator (linac) MRI-RT improves dose delivery and reduces dose spillage into surrounding tissues, enhancing the safety and efficacy of spinal stereotactic ablative radiotherapy (SABR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. Llorente, R., Spieler, BO., Victoria, J., et al.[2022]

The Elekta Unity MR-Linac (MRL) has been shown to be feasible for spine stereotactic body radiotherapy (SBRT), with treatment plans comparable in quality to those generated by conventional linear accelerators.

Dose measurements indicated that while the MRL delivered slightly lower doses to the lumbar spine compared to conventional Linacs, it performed similarly for the thoracic spine, suggesting that further optimization of treatment planning is needed for best outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of spinal stereotactic body radiotherapy in Elekta Unity® MR-Linac. Han, EY., Aima, M., Hughes, N., et al.[2021]

The 0.35 T MRI-guided linear accelerator (MRL) can create clinically acceptable stereotactic radiosurgery (SRS) plans for brain tumors with diameters up to 2.25 cm, demonstrating its feasibility for treating smaller lesions.

For larger brain tumors (greater than 2.25 cm), conventional linacs using noncoplanar beams are more effective, as they significantly spare normal brain tissue and achieve better conformity in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of brain stereotactic radiosurgery with a 0.35 T MRI-guided linac and comparison vs a C-arm-mounted linac. Slagowski, JM., Redler, G., Malin, MJ., et al.[2021]

The study demonstrated that using the Monaco treatment planning system for thoracic spine SBRT significantly improved the minimum dose to the gross tumor volume (GTVmin) compared to previous Pinnacle plans, while still preserving spinal cord safety.

The adaptive treatment plans generated with the Monaco system maintained consistent quality and safety, particularly with the adapt-to-shape (ATS) workflow, which kept spinal cord dose increases minimal (within 3% of reference plans) while allowing for effective tumor dose escalation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric analysis of MR-LINAC treatment plans for salvage spine SBRT re-irradiation. Han, EY., Yeboa, DN., Briere, TM., et al.[2022]

In a study involving 10 patients with liver metastases, MR-guided stereotactic body radiotherapy (MRgSBRT) demonstrated excellent visibility of tumors without the need for fiducial markers, indicating a promising non-invasive treatment option.

The treatment was well-accepted by patients, with no reported cases of symptomatic radiation-induced liver disease after a median follow-up of 10 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. Gani, C., Boeke, S., McNair, H., et al.[2022]

The integrated MR-Linac platform demonstrated a high localization accuracy of 1.0 ± 0.1 mm, indicating precise targeting for stereotactic radiosurgery.

The treatment plans showed excellent dosimetric accuracy, with a 96.87% success rate in meeting the 3%/1 mm gamma criteria, confirming the system's effectiveness in delivering accurate radiation doses to multiple brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a magnetic resonance guided linear accelerator for stereotactic radiosurgery treatment. Wen, N., Kim, J., Doemer, A., et al.[2018]

In a study of 139 patients with vestibular schwannoma and brainstem compression, linac-based stereotactic radiosurgery (SRS) demonstrated a 100% rate of freedom from serious brainstem toxicity after 5 years, indicating its safety for this condition.

The treatment also showed a 90% success rate in preventing tumor enlargement that would require further intervention, highlighting its efficacy in managing vestibular schwannoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Vestibular Schwannoma With Radiographic Brainstem Compression. De Leo, AN., Shah, A., Li, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9911688/

MRI-LINAC: A transformative technology in radiation oncology MRgRT could fundamentally transform the radiotherapy delivery process within radiation oncology centers through the reorganization of the patient and treatment ...

2. link.springer.com link.springer.com/article/10.1007/s00066-025-02401-3

a new indication for the MR-linac Stereotactic body radiotherapy (SBRT) is associated with good local control and symptom relief in the management of spinal metastases.

3. withpower.com withpower.com/trial/phase-2-spinal-diseases-5-2023-98d2a

Spinal Radiosurgery with MR-LINAC for Spinal Diseases Research shows that MR-LINAC, which combines MRI and radiation therapy, provides clear imaging of the spinal cord and tumors, allowing for precise targeting ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12304675/

Spine Stereotactic Body Radiation Therapy for a Patient With ... The advantages make the low-field MRgRT suitable for spine SBRT, especially for patients with metallic implants. Here, we present a case of ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00663

Stereotactic Body Radiation Therapy Using a MR LINAC ... A MR LINAC provides more advanced images of the spine during radiation treatment. Using a MR LINAC during SBRT may lead to improved responses to treatment and a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813892/

MR-LINAC, a New Partner in Radiation Oncology This review focuses on the characteristics of this new technology in radiation oncology, its use for the treatment of different types of solid ...

7. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00130-7/pdf

Spine Stereotactic Body Radiation Therapy for a Patient ... Abbreviations: FOV = field of view; LINAC = linear accelerator; MR = magnetic resonance; MRI = magnetic resonance imaging. Figure 5 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03284619?tab=table

NCT03284619 | First-In Man (FIM) Study MR-Linac Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).