Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Brain Neoplasm Clinical Trial

Official title:

Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05516485
• Other study ID #: 6B-20-2
• Secondary ID: NCI-2021-058516B
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Janet Jaime
• Phone: 323-865-3205
• Email: Janet.jaime[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms

Intervention

Other:
• Assessment
Undergo grading and recording of tumor consistency/stiffness

Device:
• Magnetic Resonance Elastography
Undergo MRE

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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