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Glowing dye could help surgeons spot hidden brain tumor cells

NCT ID NCT04305470

Diagnosis Sponsor: NX Development Corp 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This phase 3 trial tested a drug called Gleolan in 108 adults with meningioma (a type of brain tumor). Patients took a single oral dose before surgery. The drug makes tumor tissue glow under special light, helping surgeons see and remove more of the tumor. The study checked if the glowing areas matched lab results for tumor tissue.

What this could mean

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

Active substance
Gleolan (aminolevulinic acid hydrochloride)
What this could lead to
If successful, Gleolan could help surgeons more completely remove meningiomas by making tumor tissue glow during surgery.
What could go wrong
This is a single-arm study with no placebo group, so results may be less definitive. The drug may not work for all tumor types or locations.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

108 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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. A pre-operative MRI within ≤ 90 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a meningioma resection is indicated and has been planned. 2. Adult age ≥ 18 years. 3. Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC. 4. Patient must have recording of each parameter as defined below: Bilirubin Below upper limit of normal AST (SGOT) \< 2.5 X institutional upper limit of normal ALT (SGPT) \< 2.5 X institutional upper limit of normal Creatinine Below upper limit of normal OR Creatinine clearance \>60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal 5. The patient must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and German and Spanish. Translation for non-English, non-German, or non-Spanish speaking participants will be provided as appropriate by institution, as required. 6. WOCBP and men participating must agree to use highly effective forms of contraception, and men must also agree not to donate sperm for the duration of treatment, and for at least 42 days after the one time use of the study drug. Exclusion Criteria: 1. History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan. 2. Known or documented personal or family history of porphyria. 3. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness. 4. Patient has had a meningioma resection or radiation treatment within 90 days of informed consent. 5. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI (e.g. cardiac pacemaker). 6. Women who are pregnant or plan to become pregnant during study participation. 7. Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease within 90 days of informed consent. 8. Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer. 9. Simultaneous use of other potentially phototoxic substances (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period (see MOPS for detailed list). 10. Unwillingness by patient to sign consent or return for subsequent visits following surgery. 11. Any condition that in the opinion of the Investigator would exclude the patient as a viable candidate for this study.

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Conditions

The condition(s) this trial relates to.

meningioma

As listed by the trial registrant

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

Meningioma

Contacts and locations

Locations

  • Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Medical University of Vienna

    Vienna, 1090, Austria

  • NYU Langone Health

    Brooklyn, New York, 11220, United States

  • Providence St. Joseph Hospital

    Orange, California, 92868, United States

  • Southern Illinois University

    Springfield, Illinois, 62702, United States

  • Swedish Medical Center

    Englewood, Colorado, 80113, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospital Münster

    Münster, Germany

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Miami

    Coral Gables, Florida, 33136, United States

  • University of Pennsylvania- Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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