Ictal SPECT With Intra-arterial Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intra-arterial injection of tracer

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)

Group Type EXPERIMENTAL

intra-arterial injection of tracer

Intervention Type PROCEDURE

intra-arterial ictal injection of perfusion tracer

99m-Technetium Ethyl Cysteinate Dimer

Intervention Type DRUG

administration of perfusion tracer 99m Tc-ECD during epileptic seizure

intra-arterial catheter

Intervention Type DEVICE

placement of intra-arterial catheter via femoral artery

pressure injector

Intervention Type DEVICE

the injection of the perfusion tracer will be delivered with a pressure injector

Interventions

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intra-arterial injection of tracer

intra-arterial ictal injection of perfusion tracer

Intervention Type PROCEDURE

99m-Technetium Ethyl Cysteinate Dimer

administration of perfusion tracer 99m Tc-ECD during epileptic seizure

Intervention Type DRUG

intra-arterial catheter

placement of intra-arterial catheter via femoral artery

Intervention Type DEVICE

pressure injector

the injection of the perfusion tracer will be delivered with a pressure injector

Intervention Type DEVICE

Other Intervention Names

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99m Tc-ECD

Eligibility Criteria

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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