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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05957679
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Shengjing Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yu Shi, MDAnhua Wu, MDWen Cheng, MD
Principal Investigator Affiliation Shengjing HospitalShengjing HospitalShengjing Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Spinal Cord Tumors
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Diagnostic Test: - Magnetic Resonance Elastography

Undergo MRE and routine MRI

Procedure: - Assessment and Recording

Undergo grading and recording of tumor stiffness and adhesion during surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shengjing Hospital, Shenyang, Liaoning, China

Status

Recruiting

Address

Shengjing Hospital

Shenyang, Liaoning, 110000

Site Contact

Yu Shi, MD

[email protected]

+8618940259980

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