Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

NCT05516485 | Withdrawn DMC FDA Device

• 3 other identifiers: 6B-20-2NCI-2021-05851P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasm

Outcome Measures

Primary Outcomes (2)

• Tumor stiffness (hardness) (based on surgeon's grading)

  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).

  Baseline to 6 weeks

• Tumor stiffness (based on MRE)

  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).

  Baseline to 6 weeks

Study Arms (1)

Diagnostic (MRE, tumor grading)

EXPERIMENTAL

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.

Other: Assessment; Device: Magnetic Resonance Elastography

Interventions

Assessment OTHER

Undergo grading and recording of tumor consistency/stiffness

Also known as: Assess

Diagnostic (MRE, tumor grading)

Magnetic Resonance Elastography DEVICE

Undergo MRE

Also known as: MRE

Diagnostic (MRE, tumor grading)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Restraint, Physical; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mark S Shiroishi, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 25, 2022
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

US (1)