Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT06678867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2024-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a phase II, multicentre, non-randomised open-label trial with two cohorts.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours.', 'timeFrame': 'Two weeks', 'description': 'Timeframe between informed consent and surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ependymoma', 'Glioma', 'Paediatric', '5-ALA', 'Brain tumour'], 'conditions': ['Brain Tumor']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours\n* Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement\n* 3 - 18 years inclusive\n* Adequate liver and kidney function\n\n * creatinine - less than one and a half times the upper limit of normal.\n * haemoglobin above the lower limit of normal\n * Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal\n * bilirubin lower than one and a half times the upper limit of normal\n* Normal Coagulation profile\n\n o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits\n* Urine porphyrin - Test to be completed and sent for analysis\n* Blood pressure lower than or equal to the upper limit of normal\n* Negative pregnancy test in women of childbearing potential\\*\n* 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\n\nExclusion Criteria:\n\n* Patients with low grade tumours (either radiological or histological diagnosis)\n* Patient is appropriate for biopsy only, based on Investigator and MDT judgement\n* Known history (including family history) of porphyria\n* Hypersensitivity to the active substance or to porphyrins\n* History of light sensitivity reactions\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06678867', 'acronym': 'P5A', 'briefTitle': 'The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours', 'orgStudyIdInfo': {'id': 'UCL/154416'}, 'secondaryIdInfos': [{'id': 'CCLGA 2022 27 Dandapani', 'type': 'OTHER_GRANT', 'domain': "Little Princess Trust- Children's Cancer and Leukaemia Group"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with high grade brain tumours', 'description': 'This is a single-arm study with two cohorts', 'interventionNames': ['Drug: 5-ALA (Gliolan)']}], 'interventions': [{'name': '5-ALA (Gliolan)', 'type': 'DRUG', 'description': 'Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery', 'armGroupLabels': ['Patients with high grade brain tumours']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': "Nottingham Children's Hospital", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Paed 5-ALA Trial Manager', 'role': 'CONTACT', 'email': 'ctc.paed5-ala@ucl.ac.uk', 'phone': '020 7679 9860'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Following data protection guidance'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}