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Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Primary Purpose

Brain Neoplasm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assessment
Magnetic Resonance Elastography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (MRE, tumor grading)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
September 3, 2023
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05516485
Brief Title
Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography
Official Title
Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (MRE, tumor grading)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment
Other Intervention Name(s)
Assess
Intervention Description
Undergo grading and recording of tumor consistency/stiffness
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Elastography
Other Intervention Name(s)
MRE
Intervention Description
Undergo MRE
Primary Outcome Measure Information:
Title
Tumor stiffness (hardness) (based on surgeon's grading)
Description
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).
Time Frame
Baseline to 6 weeks
Title
Tumor stiffness (based on MRE)
Description
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).
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Jaime
Phone
323-865-3205
Email
Janet.jaime@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Shiroishi, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark S. Shiroishi
Phone
323-865-9914
Email
Mark.Shiroishi@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Mark S. Shiroishi

12. IPD Sharing Statement

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Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

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