Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
Study NCT ID:
NCT06172595
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging', 'timeFrame': '1 year', 'description': 'Sensitivity and specificity of \\[18F\\]FET-PET in delineating disease.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma, Malignant']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\\[18F\\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \\[18F\\]FET-PET in delineating disease. The main question\\[s\\] it aims to answer are:\n\n* whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression\n* whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or Women, aged 21 years or older at time of screening\n* Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour\n* With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field\n* Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry\n* Subject must consent to undergo all study procedures\n\nExclusion Criteria:\n\n* Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17\n* Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.\n* Proven cerebral metastases\n* IDH-mutated gliomas\n* Pregnancy/ breast-feeding'}, 'identificationModule': {'nctId': 'NCT06172595', 'acronym': 'FET PET in HGG', 'briefTitle': 'FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': '18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas', 'orgStudyIdInfo': {'id': '202112-00050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FET PET', 'description': 'Upon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH.\n\nAfter the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions.\n\nDuring these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up.\n\nAny alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis.', 'interventionNames': ['Diagnostic Test: FET PET']}], 'interventions': [{'name': 'FET PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'There is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year.', 'armGroupLabels': ['FET PET']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Chua', 'role': 'CONTACT', 'email': 'kevin.chua.l.m@singhealth.com.sg', 'phone': '65-96779867'}], 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lam', 'role': 'CONTACT', 'email': 'winnie.lam.w.c@singhealth.com.sg', 'phone': '65-8123-0904'}, {'name': 'Winnie W Lam, MBBS, FRCR, FAMS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, {'name': 'National Neuroscience Institute Singapore', 'class': 'UNKNOWN'}, {'name': 'Duke-NUS Graduate Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}