Advanced spinal radiation therapy using MR imaging
Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
This study is testing a new type of radiation therapy for spinal tumors that uses advanced imaging to see if it can better control the disease and improve patients' quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05709782 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of spinal stereotactic radiosurgery (SRSS) enhanced by Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) in treating spinal disease. The primary goal is to assess the local control of the target site after six months of treatment. Secondary objectives include measuring changes in epidural tumor volume and local control at one year. The study aims to improve treatment responses and enhance the quality of life for patients with spinal tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented spinal disease who are eligible for spine stereotactic radiosurgery.
Not a fit: Patients with highly radiosensitive cancers or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and improved quality of life for patients with spinal disease.
How similar studies have performed: Other studies have shown promise with advanced imaging techniques in radiation therapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: 1. Age ≥ 18 years old 2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) 3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review 4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed 5. Diagnosis of cancer documented 6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation 7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3 EXCLUSION CRITERIA: 1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) 2. Patients who are unable to undergo MRI of the spine with contrast 3. Patients who are pregnant
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Debra N. Yeboa, MD — M.D. Anderson Cancer Center
- Study coordinator: Debra N. Yeboa, MD
- Email: dnyeboa@mdanderson.org
- Phone: (713) 563-2415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.