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Trial Title:
Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography
NCT ID:
NCT05516485
Condition:
Brain Neoplasm
Conditions: Official terms:
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Assessment
Description:
Undergo grading and recording of tumor consistency/stiffness
Arm group label:
Diagnostic (MRE, tumor grading)
Other name:
Assess
Intervention type:
Device
Intervention name:
Magnetic Resonance Elastography
Description:
Undergo MRE
Arm group label:
Diagnostic (MRE, tumor grading)
Other name:
MRE
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Contact:
Last name:
Mark S. Shiroishi
Phone:
323-865-9914
Email:
Mark.Shiroishi@med.usc.edu
Investigator:
Last name:
Mark S. Shiroishi
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
October 1, 2028
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05516485
