NCT05957679

Brief Summary

In spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue. The stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure. This clinical trial aims to assess the clinical utility of magnetic resonance elastography (MRE), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2023Sep 2027

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

July 15, 2023

Last Update Submit

February 10, 2026

Conditions

Keywords

MRESlip Interface ImagingGliomaMagnetic Resonance ElastographySpinal meningiomaNeurofibromaEpendymomaAstrocytomaGlioblastomaSpinal lipoma

Outcome Measures

Primary Outcomes (2)

  • Surgical assessment of tumor stiffness

    The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.

    Baseline to 6 weeks

  • Surgical assessment of tumor adhesion

    The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).

    Baseline to 6 weeks

Study Arms (1)

Diagnostic(MRE, tumor grading of stiffness and adhesion)

EXPERIMENTAL

Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery. During surgery, the tumor stiffness and adhesion are assessed and recorded by the surgeon according to established evaluation criteria. It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness and adhesion before the surgery. This information is typically obtained through intraoperative assessment and observation.

Diagnostic Test: Magnetic Resonance ElastographyProcedure: Assessment and Recording

Interventions

Undergo grading and recording of tumor stiffness and adhesion during surgery

Diagnostic(MRE, tumor grading of stiffness and adhesion)

Undergo MRE and routine MRI

Also known as: MRE
Diagnostic(MRE, tumor grading of stiffness and adhesion)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings)
  • Pregnant women in the first trimester (within three months)
  • Patients with severe claustrophobia or anxiety
  • Patients with severe fever
  • Patients who can not tolerate MRE
  • Patients with vascular malformations and aneurysms.
  • Patients who do not sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

Related Publications (4)

  • Murphy MC, Huston J 3rd, Glaser KJ, Manduca A, Meyer FB, Lanzino G, Morris JM, Felmlee JP, Ehman RL. Preoperative assessment of meningioma stiffness using magnetic resonance elastography. J Neurosurg. 2013 Mar;118(3):643-8. doi: 10.3171/2012.9.JNS12519. Epub 2012 Oct 19.

    PMID: 23082888BACKGROUND
  • Hughes JD, Fattahi N, Van Gompel J, Arani A, Meyer F, Lanzino G, Link MJ, Ehman R, Huston J. Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Neurosurgery. 2015 Oct;77(4):653-8; discussion 658-9. doi: 10.1227/NEU.0000000000000892.

    PMID: 26197204BACKGROUND
  • Yin Z, Lu X, Cohen Cohen S, Sui Y, Manduca A, Van Gompel JJ, Ehman RL, Huston J 3rd. A new method for quantification and 3D visualization of brain tumor adhesion using slip interface imaging in patients with meningiomas. Eur Radiol. 2021 Aug;31(8):5554-5564. doi: 10.1007/s00330-021-07918-6. Epub 2021 Apr 14.

    PMID: 33852045BACKGROUND
  • Yin Z, Hughes JD, Trzasko JD, Glaser KJ, Manduca A, Van Gompel J, Link MJ, Romano A, Ehman RL, Huston J 3rd. Slip interface imaging based on MR-elastography preoperatively predicts meningioma-brain adhesion. J Magn Reson Imaging. 2017 Oct;46(4):1007-1016. doi: 10.1002/jmri.25623. Epub 2017 Feb 14.

    PMID: 28194925BACKGROUND

MeSH Terms

Conditions

Spinal Cord NeoplasmsGliomaMeningiomaNeurofibromaEpendymomaAstrocytomaGlioblastoma

Interventions

Elasticity Imaging TechniquesRestraint, Physical

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Vascular TissueMeningeal NeoplasmsNerve Sheath NeoplasmsPeripheral Nervous System NeoplasmsPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Yu Shi, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Anhua Wu, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Wen Cheng, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of department of radology

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations