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Ultrasound dye may help brain surgeons spot hidden tumor edges

NCT ID NCT07050836

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether injecting a contrast dye and using ultrasound during brain tumor surgery could help surgeons see the difference between tumor and healthy brain tissue. The goal was to remove more of the tumor safely. Only 2 people were enrolled before the study was stopped early, so the results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Definity contrast agent
What this could lead to
If successful, this approach could help surgeons remove more tumor tissue during brain surgery, potentially improving outcomes for glioma patients.
What could go wrong
This was a very early, tiny study (only 2 people) that was terminated early, so we have very little data. The technique may not work better than current methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

2 people

The number who actually took part.

Started

Dec 2025

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to sign and date the consent form * Stated willingness to comply with all study procedures and be available for the duration of the study * Be a male or female aged 18-95 * Have a planned standard of care surgery for presumed primary or known recurrent glioma * WHO performance status \</= 2 (equivalent Karnofsky Performance Status, KPS\>/= 70) * Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion Exclusion Criteria: * Patient at high risk of surgical site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field, or any other condition that is of increased infectious risk in the opinion of the neurosurgeon) * Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in the contrast agent. * Patient with known or suspected active or chronic infections. * Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mm Hg), uncontrolled systemic hypertension, or adult respiratory distress syndrome. * Pregnant, or breastfeeding patient. * Patient with known sickle cell disease. * Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care. * Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision.

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Conditions

The condition(s) this trial relates to.

brain cancer brain glioma glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA Glioma (any grade) in the brain

Contacts and locations

Locations

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.