- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05957679
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment
Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Spinal cord tumors are a common condition in neurosurgery, including neurofibroma, spinal meningioma, ependymoma, glioma, spinal lipoma, and so on.
Magnetic resonance imaging (MRI) plays a crucial role in the preoperative evaluation and planning of spinal cord tumor surgery. It provides detailed information about the tumor's location, size, and relationship to adjacent structures.
However, routine MRI may not always provide sufficient information about the tumor's stiffness or adhesion, which can impact surgical planning and postoperative outcomes. Magnetic resonance elastography and slip interface imaging can help measure the mechanical properties of tissues, including their stiffness or adhesion.
By combining the above methods, surgeons can identify areas of potential tumor adherence or invasion into surrounding structures, allowing for more precise surgical resection and minimizing the risk of damage to critical neural tissue.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu Shi, MD
- Phone Number: +86 189 4025 9980
- Email: 18940259980@163.com
Study Contact Backup
- Name: Wen Cheng, MD
- Phone Number: +86 150 4023 5535
- Email: cmu071207@163.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110000
- Recruiting
- Shengjing Hospital
-
Principal Investigator:
- Yu Shi, MD
-
Contact:
- Yu Shi, MD
- Phone Number: +8618940259980
- Email: 18940259980@163.com
-
Contact:
- Anhua Wu, MD
- Phone Number: +8618900925766
- Email: wuanhua@yahoo.com
-
Principal Investigator:
- Anhua Wu, MD
-
Principal Investigator:
- Wen Cheng, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients undergoing spinal cord tumor resection surgery are eligible for inclusion in the study cohort.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic(MRE, tumor grading of stiffness and adhesion)
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.
|
Undergo MRE and routine MRI
Other Names:
Undergo grading and recording of tumor stiffness and adhesion during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical assessment of tumor stiffness
Time Frame: Baseline to 6 weeks
|
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
Time Frame: Baseline to 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yu Shi, MD, Shengjing Hospital
- Principal Investigator: Anhua Wu, MD, Shengjing Hospital
- Principal Investigator: Wen Cheng, MD, Shengjing Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Central Nervous System Neoplasms
- Spinal Cord Diseases
- Glioblastoma
- Glioma
- Neurofibroma
- Meningioma
- Astrocytoma
- Ependymoma
- Spinal Cord Neoplasms
- Investigative Techniques
- Therapeutics
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Behavior Control
- Immobilization
- Ultrasonography
- Restraint, Physical
- Elasticity Imaging Techniques
Other Study ID Numbers
- ShengjingH_brain2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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