Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Not Applicable

Withdrawn

• Conditions: Brain Neoplasm
• Interventions: Other: Assessment; Device: Magnetic Resonance Elastography

• Registration Number: NCT05516485
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Study Start: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRE, tumor grading)	Magnetic Resonance Elastography	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.
Diagnostic (MRE, tumor grading)	Assessment	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.

Primary Outcome Measures

Name	Time	Method
Tumor stiffness (hardness) (based on surgeon's grading)	Baseline to 6 weeks	Surgeon will grade tumor stiffness based on the Zada scale of 1-5, with stiffer tumors receiving higher scores on the scale, as follows: 1) extremely soft tumor, internal debulking with suction only; 2) soft tumor, internal debulking mostly with suction, and remaining fibrous strands resected with easily folded capsule; 3) average consistency, tumor cannot be freely suctioned and requires mechanical debulking, and the capsule then folds with relative ease; 4) firm tumor, high degree of mechanical debulking required, and capsule remains difficult to fold; and 5) extremely firm, calcified tumor, approaches density of bone, and capsule does not fold. Outcome will be further dichotomized into two categories: soft (1, 2) vs. stiff (hard).
Tumor stiffness (based on MRE)	Baseline to 6 weeks	The tumor stiffness as measured by MRE in kilopascals (kPa) will be analyzed to establish 2 cut-points. (1) Higher cut-point: Because higher kPa is a quality of stiffer (harder) tumors the high cut off point will be the kPa at which no tumor greater than or equal to that value can be called soft. (2) Lower cut-point: this will be the kPa at which no tumor lower than or equal to that value can be called stiff (hard).

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States