Glow-in-the-Dark brain surgery: new hope for kids with tumors?
NCT ID NCT06907485
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called Gleolan (5-ALA) can make brain tumors glow during surgery in children aged 2 to 18. The drug is already used in adults to help surgeons remove more tumor tissue. Twenty children with suspected gliomas will drink the drug before surgery, and doctors will check how well the tumor lights up. The main goal is to see if this approach is feasible and safe in kids.
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, also called 5-ALA)
- What this could lead to
- If it works, this could help surgeons remove more of a child's brain tumor during surgery by making the tumor glow, potentially improving outcomes.
- What could go wrong
- This is a small, early feasibility study with only 20 children, so results may not apply to all. The drug can cause sun sensitivity, requiring children to stay in dim light for 2 days after surgery.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Subjects included in this trial must have had an MRI documentation of "a new or recurrent primary pediatric brain tumor" for which resection is indicated and has been planned. 2. The anticipated histology at resection will be "newly diagnosed" or "recurrent": pilocytic astrocytoma, pleomorphic xanthoastrocytoma (PXA), ganglioglioma, diffuse neuroepithelial tumor (DNET), astrocytoma, oligodendroglioma, ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic ganglioglioma, anaplastic PXA, PNET, ATRT, or medulloblastoma. 3. Male or Female Age 2-17 years and 182 days 4. Subjects must have normal organ and marrow function as defined below: Leukocytes \>3,000/mL Platelets \>100,000/mL Total bilirubin Below upper limit of normal (ULN) AST (SGOT)/ALT (SGPT)/ GGT \<2.5 X institutional age-specific ULN Creatinine Below ULN OR Creatinine Clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional age-specific normal as defined per institution. 5. The effects of 5-ALA on the developing human fetus are unknown. A pregnancy test will be performed for all young women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a young woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 6. Ability for patient/patient's guardian to understand and the willingness to sign a written informed consent document. In appropriate cases, assent of pediatric patients will be obtained. Translation will be provided as appropriate. 7. Inclusion of Women and Minorities: Both males and females and members of all ethnic groups are eligible for this trial. Exclusion Criteria: 1. Patients who meet inclusion criteria but are unable to swallow 5-ALA solution. 2. Patients with radiographic tumors of the brain stem as assessed by MRI. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA. Patients should refrain from use of other potential phototoxic substances (e.g., tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 24 h. 4. Personal or family history of porphyria. 5. Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, heart disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated 5-ALA. 6. Young women who are pregnant or become pregnant will be excluded from the trial as it is unknown if 5-ALA is teratogenic or has abortifacient effects. A pregnancy test will be performed on all young women who are s/p menstruation prior to entering study. 7. Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge
Chicago, Illinois, 60068, United States
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
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