Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01089868
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2010-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-05', 'studyFirstSubmitDate': '2010-03-17', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '46 months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '46 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioblastoma multiforme', 'Microsurgery', 'Stereotactic biopsy', 'Radiochemotherapy', 'Temodar', 'FET PET', 'Molecular imaging'], 'conditions': ['Glioblastoma Multiforme']}, 'referencesModule': {'references': [{'pmid': '28079702', 'type': 'DERIVED', 'citation': 'Ingrisch M, Schneider MJ, Norenberg D, Negrao de Figueiredo G, Maier-Hein K, Suchorska B, Schuller U, Albert N, Bruckmann H, Reiser M, Tonn JC, Ertl-Wagner B. Radiomic Analysis Reveals Prognostic Information in T1-Weighted Baseline Magnetic Resonance Imaging in Patients With Glioblastoma. Invest Radiol. 2017 Jun;52(6):360-366. doi: 10.1097/RLI.0000000000000349.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neuroradiologically suspected Glioblastoma multiforme\n* histological verification will be obtained either by microsurgery or by stereotactic biopsy. The neuropathological diagnosis will be verified by a reference neuropathologist\n* patients will undergo radiochemotherapy subsequent to surgical procedure\n* patients older than 18 years\n* Karnofsky Performance Score \\>=70\n* pregnant or nursing female patients will not be included in this study\n* safe contraceptive methods during the radiochemotherapy and chemotherapy\n\nExclusion Criteria:\n\n* patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills\n* patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan\n* medical history of a metastatic brain disease\n* patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.'}, 'identificationModule': {'nctId': 'NCT01089868', 'briefTitle': 'Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis', 'orgStudyIdInfo': {'id': 'GGN-ZP9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients who suffer from a suspected GBM and will undergo a microsurgical procedure for diagnosis verification. MRI and Positron Emission Tomography (PET) scans are scheduled prior to microsurgery, post microsurgery and after having completed radiochemotherapy and an additional scan after TMZ chemotherapy.'}, {'label': 'Group B', 'description': "Patients enrolled in Group B suffer from a suspected GBM which cannot be accessed microsurgically either due to a an eloquent location of the tumor, or patient's refusal to undergo surgery. In these patients, diagnosis will be obtained by means of stereotactic surgery. After an initial PET and MRI scan prior to biopsy, patients will be monitored by post radiochemotherapy as well as post 3-months chemotherapy MRI/PET scans."}]}, 'contactsLocationsModule': {'locations': [{'zip': '79095', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of Stereotactic Neurosurgery', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Munich, Department of Neurosurgery', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Bonn, Department of Neurosurgery', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Joerg C. Tonn, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, LMU, Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Bogdana Suchorska', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}