BridgeMD
Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with brain tumors
EU CTIS ID: 2024-517575-20-00
What this study is testing
To determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with intra-axial brain tumors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 3 - <18 years
- First radiological diagnosis of intra-axial, contrast-enhancing tumor on MRI or recurrent intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
- Resection is part of therapeutic strategy with an emphasis on neurological safety
- Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial
- Female adolescents: not pregnant (pregnancy test required for adolescents of childbearing age) or breast-feeding (for at least 24 hours after Gliolan intake)
- Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials (see section 7.4).
You likely can't join if
- Extraaxial tumors such as craniopharyngeoma
- Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration
- Entities precluding surgical resection
- Acute or chronic porphyria
- Hypersensitivity to 5-ALA or porphyrins
See the full eligibility criteria
- Age 3 - <18 years
- First radiological diagnosis of intra-axial, contrast-enhancing tumor on MRI or recurrent intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
- Resection is part of therapeutic strategy with an emphasis on neurological safety
- Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial
- Female adolescents: not pregnant (pregnancy test required for adolescents of childbearing age) or breast-feeding (for at least 24 hours after Gliolan intake)
- Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials (see section 7.4).
- Extraaxial tumors such as craniopharyngeoma
- Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration
- Entities precluding surgical resection
- Acute or chronic porphyria
- Hypersensitivity to 5-ALA or porphyrins
- Renal insufficiency: serum creatinine > 2x upper limit of normal (ULN)
- Hepatic insufficiency: serum bilirubine > 2x ULN, serum γ-GT > 2,5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) > 2,5x ULN
- Blood clotting: INR out of acceptable limits
- Other malignant disease
- Patients with pre-existing cardiovascular diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.