EpilepsyNCT02513992
Ictal SPECT With Intra-arterial Injection
A study testing intra-arterial injection of tracer, 99m-Technetium Ethyl Cysteinate Dimer and intra-arterial catheter in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- intra-arterial injection of tracer, 99m-Technetium Ethyl Cysteinate Dimer and intra-arterial catheter
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Renal failure
- Allergy to contrast agents
- Fever
- Anemia
- Usage of anticoagulants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven, department of Neurology
Leuven, 3000
About this study
Official title: Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- intra-arterial injection of tracer, 99m-Technetium Ethyl Cysteinate Dimer, intra-arterial catheter, pressure injector
- Keywords
- ictal SPECT
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial injection of tracerProcedure or surgery
intra-arterial ictal injection of perfusion tracer
99m-Technetium Ethyl Cysteinate DimerDrug
Also called 99m Tc-ECD
administration of perfusion tracer 99m Tc-ECD during epileptic seizure
intra-arterial catheterDevice
placement of intra-arterial catheter via femoral artery
pressure injectorDevice
the injection of the perfusion tracer will be delivered with a pressure injector
| Study group | Role | What they receive |
|---|---|---|
| intra-arterial injection of tracer | Experimental | 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) Receives: Procedure: intra-arterial injection of tracer; Drug: 99m-Technetium Ethyl Cysteinate Dimer; Device: intra-arterial catheter; Device: pressure injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after epilepsy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: no patient met inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr W Van Paesschen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Wim Van Paesschen, MD PhD, Principal investigator, UZ Leuven/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513992
- Sponsor's protocol ID
- S58243
- Status last verified
- Sep 2020
- First submitted
- 19 Jul 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 12690050Van Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. doi: 10.1111/j.0013-9580.2004.04008.x.
PubMed 15281956Van 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.
PubMed 17351491Goffin 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.
PubMed 18514079Tousseyn 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.
PubMed 25631544Cleeren 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.
PubMed 26174547
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ictal SPECT With Intra-arterial Injection to Localize the Ictal Onset Zone in Refractory Focal Epilepsy.
- ClinicalTrials.gov ID
- NCT02513992
- Acronym / sponsor ID
- S58243
- Conditions
- Epilepsy
- Keywords
- ictal SPECT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient met inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-arterial injection of tracer | Experimental | Procedure: intra-arterial injection of tracer, Drug: 99m-Technetium Ethyl Cysteinate Dimer, Device: intra-arterial catheter, Device: pressure injectorThe 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Renal failure
- Allergy to contrast agents
- Fever
- Anemia
- Usage of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial injection of tracerintra-arterial ictal injection of perfusion tracer | Procedure or surgery | intra-arterial injection of tracer |
| 99m-Technetium Ethyl Cysteinate DimerAlso: 99m Tc-ECDadministration of perfusion tracer 99m Tc-ECD during epileptic seizure | Drug | intra-arterial injection of tracer |
| intra-arterial catheterplacement of intra-arterial catheter via femoral artery | Device | intra-arterial injection of tracer |
| pressure injectorthe injection of the perfusion tracer will be delivered with a pressure injector | Device | intra-arterial injection of tracer |
Primary outcome
Correct localization of the ictal onset zone
Time frame: 1 year after epilepsy surgery
seizure free outcome will be assessed 1 year after epilepsy surgery and correlated with Subtracted ictal SPECT co-registered with MRI (SISCOM) results
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 12690050Van 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.
- Background: PubMed 15281956Van Paesschen W. Ictal SPECT. Epilepsia. 2004;45 Suppl 4:35-40. doi: 10.1111/j.0013-9580.2004.04008.x.
- Background: PubMed 17351491Van 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.
- Background: PubMed 18514079Goffin 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.
- Background: PubMed 25631544Tousseyn 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.
- Background: PubMed 26174547Cleeren 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Van Paesschen, MD PhD principal investigator
UZ Leuven/KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-arterial injection of tracer, 99m-Technetium Ethyl Cysteinate Dimer and intra-arterial catheter in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct localization of the ictal onset zone (time frame: 1 year after epilepsy surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513992, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.