Brain TumorNCT06630338
Use of Shear Wave Elastography for Intraoperative Brain and Tumor Stiffness Measurements
An observational study of Brain Tumor and Recurrent Brain Tumor, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Recurrent Brain Tumor, Brain Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 28 Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults >= 18 years with a brain tumor diagnosis that will undergo brain surgery with tissue resection as standard of care.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Alfredo Quinones-Hinojosa, MD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jun 2027 (estimated)
- Primary completion28 Jun 2034 (estimated)
- Study completion28 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfredo Quinones-Hinojosa, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630338
- Sponsor's protocol ID
- 24-003917
- Other IDs
- NCI-2024-07560, 24-003917
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Shear Wave Elastography for Intraoperative Brain and Tumor Stiffness Measurements
- ClinicalTrials.gov ID
- NCT06630338
- Acronym / sponsor ID
- 24-003917
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 28 Jun 2034 (estimated)
- Study completion
- 28 Jun 2034 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults >= 18 years with a brain tumor diagnosis that will undergo brain surgery with tissue resection as standard of care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfredo Quinones-Hinojosa, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Recurrent Brain Tumor, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness. (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.