Brain Neoplasm, Brain Tumor, Recurrent Brain Neoplasm, Recurrent Brain Tumor
Conditions
Brief summary
This study investigates the role of intraoperative shear wave elastography ultrasound (ISWEU) in identifying healthy brain and tumor tissue stiffness differences. This data may be used to guide tumor resection in future patients.
Detailed description
PRIMARY OBJECTIVE: I. Determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness. OUTLINE: This is an observational study. Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be at least 18 years old. * Patients must have planned surgery for resection of a newly diagnosed or recurrent brain tumors. * Patients with tumors located in the brain cortex or superficial white matter in which introduction of the ultrasound probe is straightforward and does not pose a risk for intraoperative complications. * Patients must have a Karnofsky performance status ≥ 60%. * Patient or legally authorized representative (LAR) willing to provide written informed consent.
Exclusion criteria
* Patients with deep-seated brain tumors in which introduction of the ultrasound probe poses an increased risk. * Patients with a history of any brain infections. * Patients with implanted devices. * Patients with any other neurological/neurosurgical disease that could affect tissue stiffness. * Patients with any other structural brain defect that could affect tissue stiffness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness. | At baseline | After intraoperative measurement of brain stiffness using ISWEU, analysis will be conducted after each procedure by determining the tissue stiffness from different areas (tumor core, peritumoral brain zone, and non-cancerous brain tissue) and comparing the tumor stiffness between patients. Reviewers will determine whether ISWEU is feasible to be used as a tool to influence surgical decision. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORAlfredo Quinones-Hinojosa, MD
Mayo Clinic
Outcome results
None listed