Safety Study of 5-Aminolevulinic Acid for Brain Tumor Surgery in Children and Adolescents

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What is this study about?

This clinical trial focuses on children and adolescents with brain tumors. The study will evaluate the safety of a medicine called 5-Aminolevulinic acid (5-ALA), available as Gliolan, which comes as a powder that is mixed with liquid and taken by mouth. This medicine helps surgeons see tumor tissue more clearly during brain surgery by making the tumor cells glow under special light.

The main purpose of this research is to determine if 5-ALA can be safely used for surgery in young patients when removing tumors from the brain. During the study, patients will receive a single dose of the medication before their scheduled brain surgery. The medicine is given at a dose based on the patient’s body weight, up to 20 milligrams per kilogram.

After taking the medicine, patients will undergo brain surgery where doctors will use special lighting to help them see and remove the tumor tissue. The study will monitor patients for any side effects or complications that may occur during and after the surgery. Some patients may also have blood samples taken to understand how the medicine works in young bodies.

1 Pre-surgery preparation

You will receive Gliolan, an oral solution containing 30 mg/ml of a substance called aminolevulinic acid hydrochloride

This medication helps surgeons better see tumor tissue during the operation

If you are a female of childbearing age, a pregnancy test will be required before participation

2 Surgery day

The surgical team will perform a fluorescence-guided resection of your brain tumor

During surgery, the medical team will take tissue samples from areas that show fluorescence

The surgeon will document any fluorescent areas that cannot be safely removed

3 Post-surgery monitoring

You will be monitored for any side effects or complications for 24 hours after taking Gliolan

An MRI scan will be performed shortly after the surgery to assess the results

If you have provided consent, three blood samples will be collected within 12 hours after receiving Gliolan

4 Follow-up period

If you are of reproductive age, you must use effective birth control for 6 weeks after the operation

The medical team will monitor your recovery and document any significant health changes

Your participation in the study will contribute to understanding how this medication works in young patients with brain tumors

Who Can Join the Study?

Age between 3 and 17 years old
Must have either:
- A first-time diagnosis of a brain tumor visible on MRI (magnetic resonance imaging) that shows contrast enhancement, or
- A returning brain tumor (such as malignant glioma, astrocytoma, malignant ependymoma, AT/RT, or oligodendroglioma)
Surgery must be considered a safe treatment option from a neurological perspective
Must have parental or guardian consent, and when possible, the patient’s agreement to participate after being informed about the study’s purpose and risks
For female participants:
- Must not be pregnant (pregnancy test required for teens who can become pregnant)
- Must not be breastfeeding for at least 24 hours after taking Gliolan
For sexually active participants:
- Must use effective birth control methods for up to 6 weeks after the tumor surgery
- This applies to both male and female participants

Who Cannot Join the Study?

Patients who are younger than 2 years old
Patients who are allergic to 5-ALA (a substance used to make brain tumors visible during surgery)
Patients with severe liver problems
Patients with severe kidney problems
Patients with porphyria (a rare inherited blood disorder that affects how the body makes red blood cells)
Pregnant or breastfeeding women
Patients who have taken part in another clinical trial in the past 30 days
Patients who are unable to follow study procedures
Patients with known hypersensitivity (severe allergic reactions) to any component of the study medication
Patients who cannot undergo brain surgery
Patients who have conditions that could interfere with the study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Upboajrtwdhdjncqlgyme Ewoyr Aam	Essen	Germany
Ufpekvjkuutbczipchbkm Ahofbaxz	Augsburg	Germany
Uzktaovnksefbwszdtbik Mzrlddfj Ahf	Munster	Germany
Kajhshcs dzl Uoftpnqeegyr Mfezcfkf Aua	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.01.2025
The Netherlands	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

Aminolevulinic Acid Hydrochloride

5-Aminolevulinic acid (5-ALA) is a naturally occurring compound that helps surgeons better visualize brain tumors during surgery. When given to patients before surgery, it causes tumor cells to glow pink under special blue light. This helps doctors distinguish between healthy brain tissue and tumor tissue, making the surgery more precise. The medication is taken by mouth before the surgical procedure.

Brain tumor – A condition where abnormal cells grow and multiply within the brain tissue. Brain tumors can be either primary (starting in the brain) or secondary (spreading from other parts of the body). These growths can develop in different areas of the brain and can be slow-growing or aggressive. Brain tumors can affect brain function by pressing on surrounding tissues, causing swelling, or interfering with normal brain activity. The specific symptoms depend on the tumor’s location and size within the brain. As tumors grow, they can cause changes in the pressure inside the skull.

Intra-axial brain tumor – A type of brain tumor that develops within the brain tissue itself, rather than on the outside of the brain. These tumors grow within the substance of the brain and can affect various regions. Intra-axial tumors can arise from different types of brain cells and may be located in any part of the cerebral hemispheres, brainstem, or cerebellum. They can cause various symptoms depending on their specific location within the brain tissue.

Trial ID:

2024-517575-20-00

Protocol code:

UKM2013_0034

NCT ID:

NCT04738162

Trial Phase:

Therapeutic exploratory (Phase II)

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Safety Study of 5-Aminolevulinic Acid for Brain Tumor Surgery in Children and Adolescents

What is this study about?

Who Can Join the Study?

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