Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-22 @ 9:40 PM
Study NCT ID:
NCT02513992
Status:
WITHDRAWN
Last Update Posted:
2020-09-18
First Post:
2015-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ictal SPECT With Intra-arterial Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059659', 'term': 'technetium Tc 99m bicisate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patient met inclusion criteria', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2015-07-19', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct localization of the ictal onset zone', 'timeFrame': '1 year after epilepsy surgery', 'description': 'seizure free outcome will be assessed 1 year after epilepsy surgery and correlated with Subtracted ictal SPECT co-registered with MRI (SISCOM) results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ictal SPECT'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '12690050', 'type': 'BACKGROUND', 'citation': 'Van Paesschen W, Dupont P, Van Driel G, Van Billoen H, Maes A. SPECT perfusion changes during complex partial seizures in patients with hippocampal sclerosis. Brain. 2003 May;126(Pt 5):1103-11. doi: 10.1093/brain/awg108.'}, {'pmid': '15281956', 'type': 'BACKGROUND', 'citation': 'Van Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. doi: 10.1111/j.0013-9580.2004.04008.x.'}, {'pmid': '17351491', 'type': 'BACKGROUND', 'citation': 'Van Paesschen W, Dupont P, Sunaert S, Goffin K, Van Laere K. The use of SPECT and PET in routine clinical practice in epilepsy. Curr Opin Neurol. 2007 Apr;20(2):194-202. doi: 10.1097/WCO.0b013e328042baf6.'}, {'pmid': '18514079', 'type': 'BACKGROUND', 'citation': 'Goffin K, Dedeurwaerdere S, Van Laere K, Van Paesschen W. Neuronuclear assessment of patients with epilepsy. Semin Nucl Med. 2008 Jul;38(4):227-39. doi: 10.1053/j.semnuclmed.2008.02.004.'}, {'pmid': '25631544', 'type': 'BACKGROUND', 'citation': 'Tousseyn S, Dupont P, Goffin K, Sunaert S, Van Paesschen W. Correspondence between large-scale ictal and interictal epileptic networks revealed by single photon emission computed tomography (SPECT) and electroencephalography (EEG)-functional magnetic resonance imaging (fMRI). Epilepsia. 2015 Mar;56(3):382-92. doi: 10.1111/epi.12910. Epub 2015 Jan 29.'}, {'pmid': '26174547', 'type': 'BACKGROUND', 'citation': 'Cleeren E, Casteels C, Goffin K, Janssen P, Van Paesschen W. Ictal perfusion changes associated with seizure progression in the amygdala kindling model in the rhesus monkey. Epilepsia. 2015 Sep;56(9):1366-75. doi: 10.1111/epi.13077. Epub 2015 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an established technique to localize the ictal onset zone during presurgical evaluation of refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is often not obtained. Since it takes around 30 seconds before the tracer reaches the brain after intravenous injection, ictal hyperperfusion most likely has already switched to postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta proximal to the cerebral arteries, which will allow a true ictal injection in patients with seizures of short duration.', 'detailedDescription': 'In this study, the investigators will select one patient with refractory focal epilepsy with frequent seizures of short duration, which can not be localized with early ictal SPECT with intravenous injection in a cubital vein. An arterial catheter will be inserted. The right groin will be disinfected using an alcoholic disinfectant and locally anaesthetized. The artery in the groin, the femoral artery, will be punctured. A catheter is inserted in the artery and slided towards the heart. To determine the correct position of the catheter proximal to the cerebral arteries, a contrast agent will be injected, and at the same time radiographs will be taken. The catheter will be attached and taped in the groin. The patient will be monitored with video-EEG recording. During an epileptic seizure, the perfusion tracer 99m-Technetium Ethyl Cysteinate Dimer (99mTc- ECD) dissolved in 30 cc normal saline will be injected with a pressure injector over 2 seconds. After injection, the catheter will be removed and the ictal SPECT scan will be performed. Subtracted ictal SPECT images co-registered with MRI (SISCOM) will be obtained. The investigators plan to do this study in one patient in order to assess whether this procedure is logistically possible and to determine whether subtraction images of ictal SPECT with intra-arterial injection minus interictal SPECT with intravenous injection allows localization of the ictal onset zone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory unifocal epilepsy\n* Early ictal SPECT with intravenous injection did not localize the ictal onset zone\n* Several seizure per day, or clusters of several seizures per day\n* Seizures are of short duration (i.e. less than 10-15 seconds)\n* Patient asks for epilepsy surgery\n\nExclusion Criteria:\n\n* Renal failure\n* Allergy to contrast agents\n* Fever\n* Anemia\n* Usage of anticoagulants\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02513992', 'briefTitle': 'Ictal SPECT With Intra-arterial Injection', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.', 'orgStudyIdInfo': {'id': 'S58243'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intra-arterial injection of tracer', 'description': 'The perfusion tracer 99m-Technetium Ethyl Cysteinate Dimer will be injected via an intra-arterial catheter by a pressure injector to obtain a subtracted ictal SPECT co-registered with MRI (SISCOM)', 'interventionNames': ['Procedure: intra-arterial injection of tracer', 'Drug: 99m-Technetium Ethyl Cysteinate Dimer', 'Device: intra-arterial catheter', 'Device: pressure injector']}], 'interventions': [{'name': 'intra-arterial injection of tracer', 'type': 'PROCEDURE', 'description': 'intra-arterial ictal injection of perfusion tracer', 'armGroupLabels': ['intra-arterial injection of tracer']}, {'name': '99m-Technetium Ethyl Cysteinate Dimer', 'type': 'DRUG', 'otherNames': ['99m Tc-ECD'], 'description': 'administration of perfusion tracer 99m Tc-ECD during epileptic seizure', 'armGroupLabels': ['intra-arterial injection of tracer']}, {'name': 'intra-arterial catheter', 'type': 'DEVICE', 'description': 'placement of intra-arterial catheter via femoral artery', 'armGroupLabels': ['intra-arterial injection of tracer']}, {'name': 'pressure injector', 'type': 'DEVICE', 'description': 'the injection of the perfusion tracer will be delivered with a pressure injector', 'armGroupLabels': ['intra-arterial injection of tracer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven, department of Neurology', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Wim Van Paesschen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven/KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof Dr W Van Paesschen', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}