Clinical trial · Interventional
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per PI
Summary
Brief summary (as posted)
This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thoracic Spine Neoplasm | Thoracic Spine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging | Device | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device feasibility (MRI-guided surgery)
- description
- Patients undergo standard of care spine surgery with MRI-based image guidance.
- interventionNames
- Device: Magnetic Resonance Imaging
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Incidence of intraoperative adverse events
- timeFrame
- During surgery
- description
- Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson * Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.) * All diagnoses are eligible * Vertebral body site to be treated located from T2 to T12 * Signed informed consent Exclusion Criteria: * Requires open spinal procedure or a percutaneous procedure without the use of image guidance * Unable to tolerate general anesthesia and prone position * Unable to undergo MRI scan of the spine
References
Publications (0)
Data not yet available