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Ictal SPECT With Intra-arterial Injection

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intra-arterial injection of tracer
99m-Technetium Ethyl Cysteinate Dimer
intra-arterial catheter
pressure injector
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring ictal SPECT

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven, department of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intra-arterial injection of tracer

Arm 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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 19, 2015
Last Updated
September 17, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02513992
Brief Title
Ictal SPECT With Intra-arterial Injection
Official Title
Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no patient met inclusion criteria
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
ictal SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intra-arterial injection of tracer
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
intra-arterial injection of tracer
Intervention Description
intra-arterial ictal injection of perfusion tracer
Intervention Type
Drug
Intervention Name(s)
99m-Technetium Ethyl Cysteinate Dimer
Other Intervention Name(s)
99m Tc-ECD
Intervention Description
administration of perfusion tracer 99m Tc-ECD during epileptic seizure
Intervention Type
Device
Intervention Name(s)
intra-arterial catheter
Intervention Description
placement of intra-arterial catheter via femoral artery
Intervention Type
Device
Intervention Name(s)
pressure injector
Intervention Description
the injection of the perfusion tracer will be delivered with a pressure injector
Primary Outcome Measure Information:
Title
Correct localization of the ictal onset zone
Description
seizure free outcome will be assessed 1 year after epilepsy surgery and correlated with Subtracted ictal SPECT co-registered with MRI (SISCOM) results
Time Frame
1 year after epilepsy surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Van Paesschen, MD PhD
Organizational Affiliation
UZ Leuven/KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven, department of Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
12690050
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.
Results Reference
background
PubMed Identifier
15281956
Citation
Van Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. doi: 10.1111/j.0013-9580.2004.04008.x.
Results Reference
background
PubMed Identifier
17351491
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.
Results Reference
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PubMed Identifier
18514079
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.
Results Reference
background
PubMed Identifier
25631544
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.
Results Reference
background
PubMed Identifier
26174547
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.
Results Reference
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Ictal SPECT With Intra-arterial Injection

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