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Can a simple dye help surgeons see brain tumors in real time?

NCT ID NCT02691923

Diagnosis Sponsor: David W. Roberts 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a fluorescent dye called fluorescein can help surgeons identify brain tumor tissue during an operation. About 30 adults with suspected glioma will receive the dye before surgery, and the surgeon will look for glowing areas through a special microscope. The dye's performance will be compared with standard MRI scans and tissue analysis to see if it can reliably mark tumor boundaries.

What this could mean

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

Active substance
fluorescein dye and 5-aminolevulinic acid (ALA) given before surgery to help visualize tumor tissue
What this could lead to
If successful, this approach could give surgeons a real-time, dye-based tool to more precisely remove brain tumors during surgery.
What could go wrong
This is a small, early-phase trial focused on diagnostic accuracy, not treatment. The dye may not reliably distinguish tumor from healthy tissue in all cases.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Start date

Mar 2016

Expected to finish

Dec 2028

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

21 years and older

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: 1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme). 2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. 3. Valid informed consent by subject or subject's LAR. 4. No serious associated psychiatric illnesses. 5. Age ≥ 21 years old. Exclusion Criteria: 1. Pregnant women or women who are breast feeding. 2. History of hypersensitivity to fluorescein. 3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis. 4. History of liver disease within the last 12 months. 5. Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery. 6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery. 7. Inability to comply with the photosensitivity precautions associated with the study.

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Conditions

The condition(s) this trial relates to.

brain cancer glioma low grade glioma malignant glioma

As listed by the trial registrant

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

Brain cancer

Contacts and locations

Locations

  • Sally B Mansur

    Lebanon, New Hampshire, 03756, United States

More trials for these conditions

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