Clinical trial · Interventional
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). The purpose of this study is to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI. In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.
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 |
|---|---|---|---|
| Spinal Tumor | Spinal Cord Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Postoperative Magnetic Resonance Imaging
- description
- Three MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative.
- interventionNames
- Device: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging
- timeFrame
- Up to 3 weeks after surgery
- description
- Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery (aka: later imaging) leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI (within 72 hours, aka: early imaging).
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space * Operated for debulking, decompression or separation surgery; * A magnetic resonance imaging (MRI) scan performed within 72 hours after surgery is needed; * Image quality acceptable for comparison with later MRI as read by a neuroradiologist; * Karnofsky score of 60 or higher; * Able to consent for the study. Exclusion Criteria: * Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes. * Intradural extension of the tumor. * Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study. * Patient not able to tolerate MRI scan due to claustrophobia or severe pain or allergic reaction to contrast. * Patients with an estimated Glomerular Filtration Rate (eGFR) \< or = to 30 will be excluded to avoid issues related to contrast administration in such patients. This Glomerular Filtration Rate (GFR) threshold cutoff level is chosen per institutional policy, because below that level other measures would be required (hydration or no contrast administration). In order to keep the imaging information as uniform as possible in such a small study group, patients with a low GFR will not be enrolled in the study.
References
Publications (0)
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