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| ID | Type | Description | Link |
|---|---|---|---|
| CCLGA 2022 27 Dandapani | Other Grant/Funding Number | Little Princess Trust- Children's Cancer and Leukaemia Group |
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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
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The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour.
Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with high grade brain tumours | Other | This is a single-arm study with two cohorts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ALA (Gliolan) | Drug | Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours. | Timeframe between informed consent and surgery | Two weeks |
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Inclusion Criteria:
Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour
Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours
Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement
3 - 18 years inclusive
Adequate liver and kidney function
Normal Coagulation profile
o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits
Urine porphyrin - Test to be completed and sent for analysis
Blood pressure lower than or equal to the upper limit of normal
Negative pregnancy test in women of childbearing potential*
Informed Consent *A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paed 5-ALA Trial Manager | Contact | 020 7679 9860 | ctc.paed5-ala@ucl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Children's Hospital | Nottingham | United Kingdom |
Following data protection guidance
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D004806 | Ependymoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a phase II, multicentre, non-randomised open-label trial with two cohorts.
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |