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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients must be at least 18 years old.

- Patients must have planned surgery for resection of a newly diagnosed or recurrent glioma.

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06630338
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alfredo Quinones-Hinojosa, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Recurrent Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: Observational

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

Interventions

Other: - Non-Interventional Study

Non-interventional study

Contact a Trial Team

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Mayo Clinic in Florida, Jacksonville, Florida

Status

Address

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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