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Glow-in-the-dark dye could help surgeons remove brain tumors completely

NCT ID NCT02191488

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tests whether a drug called 5-ALA can make brain tumor cells glow during surgery, helping surgeons see and remove the entire tumor. About 540 adults with brain tumors will receive 5-ALA before surgery, and doctors will measure how well the glow matches actual tumor tissue. The goal is to improve how completely tumors are removed, which may help patients live longer.

What this could mean

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

Active substance
5-aminolevulinic acid (5-ALA)
What this could lead to
If successful, this could help surgeons remove brain tumors more completely, potentially improving survival and reducing regrowth.
What could go wrong
This is an early-phase study focused on measuring fluorescence, not on patient outcomes. The technique may not work for all tumor types or may not improve surgical results.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 540 people

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

Started

Jul 2014

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: * Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma * Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. * Patient or LAR able to provide written informed consent. * No serious associated psychiatric illnesses. * Age \> 21 years old. Exclusion Criteria: * Pregnant women or women who are breast feeding * History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis. * History of liver disease within the last 12 months. * Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery. * Inability to comply with the photosensitivity precautions associated with the study. * Plasma creatinine in excess of 180umol/L within 30 days prior to surgery

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm glioma meningioma metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Brain tumors

Contacts and locations

Locations

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

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