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Radiation Therapy
Spinal Radiosurgery with MR-LINAC for Spinal Diseases
Phase 2
Recruiting
Led By Debra N. Yeboa, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of cancer documented
Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial will test if using MR-LINAC imaging with spinal radiation (SRSS) helps improve responses & quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, inflammation around the spine, changes in bowel or bladder habits, and rarely nerve damage which could affect muscle strength and sensation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer diagnosis is officially recorded.
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My spine cancer has spread to no more than 3 connected vertebrae.
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My muscle strength in the limb affected by my spinal condition is good.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (Imaging-only Cohort)Experimental Treatment2 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 Treatment3 Interventions
Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
2 Trials studying Spinal Diseases
52 Patients Enrolled for Spinal Diseases
Debra N. Yeboa, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer diagnosis is officially recorded.My cancer type is known to respond well to radiation therapy alone.My doctor has approved me for specialized spine radiation therapy.My spine cancer has spread to no more than 3 connected vertebrae.My muscle strength in the limb affected by my spinal condition is good.I am 18 years old or older.My spine condition was confirmed by imaging within the last month.I can care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (Therapeutic Cohort)
- Group 2: Group 2 (Imaging-only Cohort)
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.
To what extent are individuals in Group 1 (Therapeutic Cohort) at risk?
"The safety of Group 1 (Therapeutic Cohort) was assessed at a 2 on our scale, as this is Phase 2 trial with data indicating its security but not yet validating its efficacy."
Answered by AI
Are new participants being welcomed into this experiment?
"As documented on clinicaltrials.gov, this medical study is not currently recruiting participants; the original posting was made back in June 30th 2023 and last modified January 24th 2021. Despite that, there are 38 alternative trials actively searching for volunteers at present."
Answered by AI
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