Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography
February 27, 2025 updated by: University of Southern California
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Undergo grading and recording of tumor consistency/stiffness
Other Names:
Undergo MRE
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor stiffness (hardness) (based on surgeon's grading)
Time Frame: 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).
|
Baseline to 6 weeks
|
|
Tumor stiffness (based on MRE)
Time Frame: 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).
|
Baseline to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark S Shiroishi, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Study Registration Dates
First Submitted
July 15, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6B-20-2 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2021-05851 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.