Spinal DiseasePhase 2NCT05709782
Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
A Phase 2 study testing Spine Radiosurgery, Magnetic Resonance imaging and MR-LINAC in people with Spinal Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Spine Radiosurgery, Magnetic Resonance imaging and MR-LINAC
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 13 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
- Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
- Diagnosis of cancer documented
- Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
- Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3
Who cannot join
- Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
- Patients who are unable to undergo MRI of the spine with contrast
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Debra Yeboa, MD, 713-563-2415, dnyeboa@mdanderson.org
Debra N. Yeboa, MD
About this study
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.
Read the detailed description
Primary objective:
- To determine the 6-month local control (LC) of the target site of treatment.
Secondary Objectives:
- To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
- To determine the 1-year local control of the target site
- Conditions
- Spinal Disease
- Being tested
- Spine Radiosurgery, Magnetic Resonance imaging, MR-LINAC
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine RadiosurgeryProcedure or surgery
scan
Magnetic Resonance imagingDevice
scan
MR-LINACRadiation
scan
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Therapeutic Cohort) | Experimental | Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine. Receives: Procedure: Spine Radiosurgery; Device: Magnetic Resonance imaging; Radiation: MR-LINAC |
| Group 2 (Imaging-only Cohort) | Experimental | 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. Receives: Procedure: Spine Radiosurgery; Device: Magnetic Resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
- D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start9 May 2023
- Primary completion13 Jan 2029 (estimated)
- Study completion13 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra N. Yeboa, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709782
- Sponsor's protocol ID
- 2022-0589
- Other IDs
- NCI-2023-00663
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
- ClinicalTrials.gov ID
- NCT05709782
- Acronym / sponsor ID
- 2022-0589
- Conditions
- Spinal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 13 Jan 2029 (estimated)
- Study completion
- 13 Jan 2029 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective:
- To determine the 6-month local control (LC) of the target site of treatment.
Secondary Objectives:
- To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
- To determine the 1-year local control of the target site
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Therapeutic Cohort) | Experimental | Procedure: Spine Radiosurgery, Device: Magnetic Resonance imaging, Radiation: MR-LINACParticipants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine. |
| Group 2 (Imaging-only Cohort) | Experimental | Procedure: Spine Radiosurgery, Device: Magnetic Resonance imagingParticipants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
- Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
- Diagnosis of cancer documented
Key exclusion criteria (3 listed)
- Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
- Patients who are unable to undergo MRI of the spine with contrast
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine Radiosurgeryscan | Procedure or surgery | Group 1 (Therapeutic Cohort), Group 2 (Imaging-only Cohort) |
| Magnetic Resonance imagingscan | Device | Group 1 (Therapeutic Cohort), Group 2 (Imaging-only Cohort) |
| MR-LINACscan | Radiation | Group 1 (Therapeutic Cohort) |
Primary outcome
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
Time frame: through study completion; an average of 1 year
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debra N. Yeboa, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spine Radiosurgery, Magnetic Resonance imaging and MR-LINAC in people with Spinal Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debra N. Yeboa, MD ((713) 563-2415, dnyeboa@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.