Brain Neoplasm
Conditions
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.
Interventions
OTHERAssessment
Undergo grading and recording of tumor consistency/stiffness
Undergo MRE
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
United States
Outcome results
None listed