Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

NCT ID: NCT05516485

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-10-01

Brief Summary

This clinical trial tests whether a new imaging technique called magnetic resonance elastography (MRE) is useful in determining the consistency of brain tumors and whether this could be used to guide surgical planning and choice of approach (the type of surgery that is needed) for patients with brain tumors. Comparing MRE with the typical magnetic resonance imaging (MRI) scan may help researchers assess the quality, reliability, and diagnostic utility of this scan when evaluating brain tumors.

Detailed Description

PRIMARY OBJECTIVES:

I. Examine tolerance interval of MRE measurement in kilopascals (kPa) and associated distribution of percent stiff (hard) and soft tumors above the higher limit and below the lower limit.

II. Through machine learning with MRE and clinical/demographic factors, to identify diagnostic thresholds in separating stiff tumor from soft tumor.

OUTLINE:

Patients undergo MRE scan over 25 minutes before surgery at the time of standard of care pre-operative MRI scan. On the day of surgery, the surgeon grades and records tumor consistency/stiffness during the operation and afterwards.

Conditions

Brain Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (MRE, tumor grading)

Patients undergo MRE scan over 25 minutes before surgery at the time of standard of care pre-operative MRI scan. On the day of surgery, the surgeon grades and records tumor consistency/stiffness during the operation and afterwards.

Group Type: EXPERIMENTAL

Assessment

Intervention Type: OTHER

Undergo grading and recording of tumor consistency/stiffness

Magnetic Resonance Elastography

Intervention Type: DEVICE

Undergo MRE

Interventions

Assessment

Undergo grading and recording of tumor consistency/stiffness

Intervention Type: OTHER

Magnetic Resonance Elastography

Undergo MRE

Intervention Type: DEVICE

Other Intervention Names

Assess; MRE

Eligibility Criteria

Inclusion Criteria

• All patients 18 years of age or older who undergo surgical resection for brain tumor at Keck Medical Center of University of South Carolina (USC) are eligible for inclusion into this study

Exclusion Criteria

• Patients who cannot tolerate MRE
• Those ineligible for MRI due to metallic implants, claustrophobia, or body habitus too large to fit in our MRI machine
• Those not undergoing surgical resection of brain tumor
• Children under the age of 18, pregnant women, wards of the state, and prisoners
• There will be no exclusion of patients based on gender, racial or ethnic origin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S Shiroishi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2021-05851

Identifier Type: REGISTRY

Identifier Source: secondary_id

6B-20-2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6B-20-2

Identifier Type: -

Identifier Source: org_study_id