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Real-Time 'Optical Biopsy' could help surgeons spot brain tumors Mid-Operation

NCT ID NCT06087393

Knowledge-focused Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a handheld microscope called CONVIVO that gives surgeons real-time, high-resolution images of brain tissue during surgery. The goal is to see if it can easily tell healthy tissue from tumor tissue in 30 patients with brain tumors. If it works, it could help surgeons remove tumors more completely and safely.

What this could mean

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

What this could lead to
If successful, this could help surgeons remove brain tumors more precisely by seeing tissue details in real time during surgery.
What could go wrong
This is a small, early feasibility study with only 30 patients, so results may not apply to everyone. The device is already FDA cleared, but its usefulness for brain surgery is still being tested.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * . The patient is suffering from an intracranial lesion requiring surgery: * Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors. * Patients undergoing neurosurgical resection for other brain tumors,. * All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use Exclusion Criteria: * History of hypersensitivity to fluorescein * History of allergy or bronchial asthma * Renal failure - Children (patients less than 18 years of age) * Pregnant women * Breast feeding women * Patients with inability to give informed consent

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm primary brain neoplasm

As listed by the trial registrant

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

Brain tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

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