Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05516485
Collaborator
National Cancer Institute (NCI) (NIH)
200
1
1
36
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment
  • Device: Magnetic Resonance Elastography
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography
Anticipated Study Start Date :
Sep 19, 2022
Anticipated Primary Completion Date :
Sep 19, 2024
Anticipated Study Completion Date :
Sep 19, 2025

Arms and Interventions

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.

Other: Assessment
Undergo grading and recording of tumor consistency/stiffness
Other Names:
  • Assess
  • Device: Magnetic Resonance Elastography
    Undergo MRE
    Other Names:
  • MRE
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mark S Shiroishi, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT05516485
    Other Study ID Numbers:
    • 6B-20-2
    • NCI-2021-05851
    • 6B-20-2
    • P30CA014089
    First Posted:
    Aug 25, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022