ClinicalTrials.gg
RecruitingNCT05709782Updated Jul 21, 2026

Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

A Phase 2 interventional study of Spine Radiosurgery and Magnetic Resonance imaging in Spinal Disease, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Spinal Disease

Browse trials for

03

In context

Spinal Diseases

174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 106 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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. Performance score (KPS) ≥ 40 or score ≤ 3

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group 1 (Therapeutic Cohort)

    Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

    Procedure: Spine Radiosurgery · Device: Magnetic Resonance imaging · Radiation: MR-LINAC

  • Experimental
    Group 2 (Imaging-only Cohort)

    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.

    Procedure: Spine Radiosurgery · Device: Magnetic Resonance imaging

Interventions

  • ProcedureSpine Radiosurgery

    scan

  • DeviceMagnetic Resonance imaging

    scan

  • RadiationMR-LINAC

    scan

06

What researchers measure

Primary outcomes

  1. M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires

    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.

    Time frame: through study completion; an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Jan 2029, 68 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2023
First posted
Feb 2, 2023
StartActual
May 9, 2023
Primary completionEst.
Jan 13, 2029
CompletionEst.
Jan 13, 2029
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05709782
Responsible party
Sponsor
First posted
Feb 2, 2023
Start date
May 9, 2023
Primary completion
Jan 13, 2029 (estimated)
Completion
Jan 13, 2029 (estimated)
Last update
Jul 21, 2026

Study contacts

Debra N. Yeboa, MD
Contact
dnyeboa@mdanderson.org
(713) 563-2415
Debra N. Yeboa, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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