What side effects are associated with this type of intervention?

Common side effects of treatments for spinal metastases, such as stereotactic body radiation therapy (SBRT) and magnetic resonance image-guided radiotherapy (MRgRT), include fatigue, skin irritation, and transient pain flare-ups. Less common but more serious side effects can include radiation-induced myelopathy, vertebral compression fractures, and damage to surrounding organs or tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for spinal metastases that involve advanced radiotherapy techniques. Stereotactic body radiation therapy (SBRT) is a standard-of-care treatment for spinal metastases, providing precise, high-dose radiation to target tumors while sparing surrounding healthy tissue. Additionally, magnetic resonance image-guided radiotherapy (MRgRT) has been explored for its potential to enhance treatment accuracy and adapt to changes in tumor position or size. These advanced radiotherapy methods aim to improve outcomes and reduce treatment times for patients with spinal metastases.

What other types of research exist?

Promising alternatives to SMART for spinal metastases include: 1) Stereotactic Body Radiotherapy (SBRT), which delivers high-dose radiation precisely to the tumor while sparing surrounding tissue; 2) External Beam Radiation Therapy (EBRT) with advanced imaging techniques for better targeting; 3) Bone-targeted radioisotopes like Radium-223 (Ra-223), which prolong survival and reduce symptomatic skeletal-related events; and 4) Systemic therapies such as abiraterone/prednisone, enzalutamide, and docetaxel, which have shown efficacy in reducing bone pain and improving quality of life in metastatic prostate cancer patients.

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Radiation

Stereotactic MRI-guided Adaptive Radiotherapy for Metastases of the Spine

N/A

Waitlist Available

Led By Lauren Henke, M.D., M.S.C.I.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method using MRI scans to plan and deliver radiation therapy for spine cancer. It targets patients with spinal metastases to reduce the time from consultation to treatment. The new method aims to be quicker by using detailed MRI images instead of CT scans.

Who is the study for?

This trial is for adults with spine metastases who are fit for SBRT, have had a recent diagnostic scan, and can sign an informed consent. They must not have had prior radiotherapy in the treatment area, be pregnant or breastfeeding, or have conditions that exclude them from MR imaging or make them unfit for SBRT.

What is being tested?

The study tests a new approach using the MRIdian Linac System to perform same-session MRI-only simulation and Stereotactic MRI-guided Adaptive Radiotherapy (SMART) on spinal metastases. The goal is to start treatment within days of consultation rather than weeks.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include skin reactions, fatigue, discomfort at the site of radiation, and potential aggravation of existing symptoms due to spine involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic MRI-guided Adaptive RadiotherapyExperimental Treatment2 Interventions

-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRIdian Linac System from ViewRay

2019

N/A

~10

Stereotactic MRI-guided Adaptive Radiotherapy

2019

N/A

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal metastases, such as stereotactic body radiation therapy (SBRT) and magnetic resonance image-guided radiotherapy (MRgRT), work by delivering high doses of radiation precisely to the tumor. This precision is achieved through advanced imaging techniques that allow for real-time adjustments during treatment. The primary mechanism of action is the induction of DNA damage in cancer cells, leading to cell death and tumor shrinkage. This is crucial for patients with spinal metastases as it helps to alleviate pain, prevent further spinal cord compression, and improve overall quality of life.