## Protocol Section
### Identification Module
**NCT ID:** NCT05957679

**Brief Title:** MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment

**Official Title:** Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography

#### Organization Study ID Info
**ID:** ShengjingH_brain2023
#### Organization
**Class:** OTHER
**Full Name:** Shengjing Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-25

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-07-24
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-15
**Study First Submit QC Date:** 2023-07-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shengjing Hospital

#### Responsible Party

**Investigator Affiliation:** Shengjing Hospital

**Investigator Full Name:** Yu Shi

**Investigator Title:** Deputy director of department of radology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Spinal Cord Tumors

**Keywords:**

- MRE

- Slip Interface Imaging

- Glioma

- Magnetic Resonance Elastography

- Spinal meningioma

- Neurofibroma

- Ependymoma

- Astrocytoma

- Glioblastoma

- Spinal lipoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Magnetic Resonance Elastography

- Procedure: Assessment and Recording

**Label:** Diagnostic（MRE, tumor grading of stiffness and adhesion）

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diagnostic（MRE, tumor grading of stiffness and adhesion）

**Description:** Undergo MRE and routine MRI

**Name:** Magnetic Resonance Elastography

**Other Names:**

- MRE

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Diagnostic（MRE, tumor grading of stiffness and adhesion）

**Description:** Undergo grading and recording of tumor stiffness and adhesion during surgery

**Name:** Assessment and Recording

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Surgical assessment of tumor stiffness

**Time Frame:** Baseline to 6 weeks

**Description:** 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).

**Measure:** Surgical assessment of tumor adhesion

**Time Frame:** Baseline to 6 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 18940259980@163.com

**Name:** Yu Shi, MD

**Phone:** +86 189 4025 9980

**Role:** CONTACT

**Contact 2:**

**Email:** cmu071207@163.com

**Name:** Wen Cheng, MD

**Phone:** +86 150 4023 5535

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shenyang

**Contacts:**

***Contact 1:***

- **Email:** 18940259980@163.com

- **Name:** Yu Shi, MD

- **Phone:** +8618940259980

- **Role:** CONTACT

***Contact 2:***

- **Email:** wuanhua@yahoo.com

- **Name:** Anhua Wu, MD

- **Phone:** +8618900925766

- **Role:** CONTACT

***Contact 3:***

- **Name:** Yu Shi, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Anhua Wu, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Wen Cheng, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shengjing Hospital

**State:** Liaoning

**Status:** RECRUITING

**Zip:** 110000

#### Overall Officials

**Official 1:**

**Affiliation:** Shengjing Hospital

**Name:** Yu Shi, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Shengjing Hospital

**Name:** Anhua Wu, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Shengjing Hospital

**Name:** Wen Cheng, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 23082888

**Citation:** 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:** 26197204

**Citation:** 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:** 33852045

**Citation:** 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. Erratum In: J Magn Reson Imaging. 2017 Dec;46(6):1851.

**PMID:** 28194925

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9020

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: M3620

- Name: Tissue Adhesions

- Relevance: LOW

- As Found: Unknown

- ID: M9019

- Name: Glioblastoma

- Relevance: LOW

- As Found: Unknown

- ID: M11562

- Name: Meningioma

- Relevance: LOW

- As Found: Unknown

- ID: M19549

- Name: Neurofibromatoses

- Relevance: LOW

- As Found: Unknown

- ID: M12398

- Name: Neurofibroma

- Relevance: LOW

- As Found: Unknown

- ID: M15917

- Name: Spinal Cord Neoplasms

- Relevance: HIGH

- As Found: Spinal Cord Tumor

- ID: M4561

- Name: Astrocytoma

- Relevance: LOW

- As Found: Unknown

- ID: M7965

- Name: Ependymoma

- Relevance: LOW

- As Found: Unknown

- ID: M11067

- Name: Lipoma

- Relevance: LOW

- As Found: Unknown

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2519

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: T2518

- Name: Glioblastoma

- Relevance: LOW

- As Found: Unknown

- ID: T3707

- Name: Meningioma

- Relevance: LOW

- As Found: Unknown

- ID: T4096

- Name: Neurofibromatosis

- Relevance: LOW

- As Found: Unknown

- ID: T4095

- Name: Neurofibroma

- Relevance: LOW

- As Found: Unknown

- ID: T2093

- Name: Ependymoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013120

- Term: Spinal Cord Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
