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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 completion of first fraction of treatment for all enrolled participants (estimated to be 48 months)
Awards & highlights
Study Summary
This trial is testing a new way to do radiation therapy for spinal metastases that is faster than the current standard. They will do a same-session MRI-only simulation and treatment, which will be given in five fractions over 1-2 weeks. The goal is to see if this is feasible and safe.
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.Check my eligibility
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.See study design
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 ~ completion of first fraction of treatment for all enrolled participants (estimated to be 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of first fraction of treatment for all enrolled participants (estimated to be 48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants to receive delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,699 Total Patients Enrolled
Lauren Henke, M.D., M.S.C.I.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
10 Total Patients Enrolled
Clifford Robinson, M.D.Principal InvestigatorWashington University School of Medicine
4 Previous Clinical Trials
139 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The radiation oncologist thinks that you are not healthy enough for SBRT treatment.You cannot have a magnetic resonance imaging (MRI) scan for medical reasons.You have received radiation therapy in the same area that will be treated with MRI-guided SBRT in the past.You have cancer that has spread to your spine and is causing spinal cord compression that is causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic MRI-guided Adaptive Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort being recruited for this research?
"Affirmative. Clinicaltrials.gov indicates that this study is actively searching for eligible participants, with the post being first published on November 6th 2019 and last updated on November 22nd 2022. The research requires 10 patients from one medical centre to be recruited."
Answered by AI
Are any new participants being welcomed into this research endeavor?
"As evidenced by clinicaltrials.gov, this study is still in search of participants. It was first posted on November 6th 2019 and has been modified for the last time on November 22nd 2022."
Answered by AI
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