Use of Shear Wave Elastography for Intraoperative Brain and Tumor Stiffness Measurements

NCT06630338 | Not Yet Recruiting

• 2 other identifiers: 24-003917NCI-2024-07560
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Recurrent Brain Tumor; Brain Neoplasm; Recurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.

  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.

  At baseline

Study Arms (1)

Observational

Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>= 18 years with a brain tumor diagnosis that will undergo brain surgery with tissue resection as standard of care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alfredo Quinones-Hinojosa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 28, 2033
• Study Completion (Estimated): June 28, 2033
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)