Study Stopped
no patient met inclusion criteria
Ictal SPECT With Intra-arterial Injection
Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 3, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 18, 2020
September 1, 2020
2.2 years
July 19, 2015
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correct localization of the ictal onset zone
seizure free outcome will be assessed 1 year after epilepsy surgery and correlated with Subtracted ictal SPECT co-registered with MRI (SISCOM) results
1 year after epilepsy surgery
Study Arms (1)
intra-arterial injection of tracer
EXPERIMENTALThe 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)
Interventions
intra-arterial ictal injection of perfusion tracer
administration of perfusion tracer 99m Tc-ECD during epileptic seizure
placement of intra-arterial catheter via femoral artery
the injection of the perfusion tracer will be delivered with a pressure injector
Eligibility Criteria
You may qualify if:
- Refractory unifocal epilepsy
- Early ictal SPECT with intravenous injection did not localize the ictal onset zone
- Several seizure per day, or clusters of several seizures per day
- Seizures are of short duration (i.e. less than 10-15 seconds)
- Patient asks for epilepsy surgery
You may not qualify if:
- Renal failure
- Allergy to contrast agents
- Fever
- Anemia
- Usage of anticoagulants
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven, department of Neurology
Leuven, 3000, Belgium
Related Publications (6)
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: 12690050BACKGROUNDVan Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. doi: 10.1111/j.0013-9580.2004.04008.x.
PMID: 15281956BACKGROUNDVan 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: 17351491BACKGROUNDGoffin 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: 18514079BACKGROUNDTousseyn 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: 25631544BACKGROUNDCleeren 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.
PMID: 26174547BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wim Van Paesschen, MD PhD
UZ Leuven/KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 19, 2015
First Posted
August 3, 2015
Study Start
May 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
September 18, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share