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

Trial Summary

What is the purpose of this trial?

To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

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 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 during treatment. This precision helps protect the spinal cord while effectively treating tumors, making it a promising option for spinal stereotactic body radiotherapy (SBRT). ^{1 2 3 4 5}

Is MR-LINAC safe for treating spinal diseases?

Research shows that MR-LINAC, which uses MRI to guide radiation therapy, provides clear imaging for precise treatment, especially for the spine, and is considered safe when used properly. It helps protect sensitive areas like the spinal cord by allowing accurate targeting of radiation. ^{1 2 3 6 7}

How is the treatment Spinal Radiosurgery with MR-LINAC different from other treatments for spinal diseases?

Spinal Radiosurgery with MR-LINAC is unique because it uses MRI (magnetic resonance imaging) to precisely target the spinal area, allowing for better visualization of the spinal cord and tumor, which helps protect healthy tissue during treatment. This approach improves accuracy compared to traditional X-ray guided methods, making it safer and potentially more effective for treating spinal diseases. ^{1 2 3 4 8}

Research Team

Debra N. Yeboa

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

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

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. [2020]

2. England pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. [2022]

3. United States 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. [2021]

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

Dosimetric analysis of MR-LINAC treatment plans for salvage spine SBRT re-irradiation. [2022]

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

Feasibility of spinal stereotactic body radiotherapy in Elekta Unity® MR-Linac. [2021]

6. Ireland 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. [2022]

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

Stereotactic Radiosurgery for Vestibular Schwannoma With Radiographic Brainstem Compression. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a magnetic resonance guided linear accelerator for stereotactic radiosurgery treatment. [2018]