Ictal SPECT With Intra-arterial Injection

Epilepsy Clinical Trial

Official title:

Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02513992
• Other study ID #: S58243
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Renal failure

• Allergy to contrast agents

• Fever

• Anemia

• Usage of anticoagulants

• Pregnancy

Related Conditions & MeSH terms

• Epilepsy

Intervention

Procedure:
• intra-arterial injection of tracer
intra-arterial ictal injection of perfusion tracer

Drug:
• 99m-Technetium Ethyl Cysteinate Dimer
administration of perfusion tracer 99m Tc-ECD during epileptic seizure

Device:
• intra-arterial catheter
placement of intra-arterial catheter via femoral artery
• pressure injector
the injection of the perfusion tracer will be delivered with a pressure injector

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, department of Neurology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Van Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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