- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550726
High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Focal epilepsy refers to having seizures arising from a specific part of the brain. In these patients, workup in magnetic resonance imaging is often necessary as patients with structural lesions have a much higher rate of seizures, ranging from 10% to 26% at 1 year and from 29% to 48% at 5 years. However, there is also a subgroup of patients who has epilepsy not adequately controlled by anti-epileptics with unrevealing first MRI study, a dedicated MRI protocol may reveal positive lesion in 30-65% of the cases. In these patients, several tricks can be applied to increase the detection rate. First, the used of a high-resolution MRI on a high-field scanner could be helpful, which can be increased the sensitivity up to 90%. The use of 7T-MRI in further picking up subtle lesions in patients presenting with epilepsy has been investigated, further affirming the role of high resolution MRI imaging. Secondly, the use of dedicated sequences, such as T1-weighted inversion recovery sequences which allow better distinction of grey and white matter, could also reveal subtle lesions such as polymicrogyria or Type 1 focal cortical dysplasia.
This study is therefore aimed to apply the findings to the local settings, and specifically to investigate if T1-weighted inversion recovery sequences provides additional benefit in picking up more subtle lesions in patients who had an initial first negative MRI.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanson Leung, MBBS (HK)
- Phone Number: 35051009
- Email: lhs655@ha.org.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Gerald Choa MRI Center
-
Contact:
- Gerald Choa MRI Center CUHK
- Phone Number: 35051009
- Email: cumri@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria -
1. Diagnosis of focal epilepsy with a probable site identified, as defined by concordant results from any TWO of the following:
- Clinical seminology compatible with focal epilepsy.
- Electroencephalography pointing towards a specific site for focal epilepsy.
- Positive ictal brain scintigraphy with SPECT-CT correlation. AND 2. Previous MRI (at least one study with protocol tailored for epilepsy) which did not reveal accountable focal lesion.
AND 3. Able to consent for MRI examination (if patient under age of 18, consent for MRI will be obtained from guardian). Patients will be provided information leaflets to read on, and written consent before taking part in this study and MRI examination.
Exclusion Criteria:
- Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)
- Patients who cannot cooperate for MRI scanning.
- Patients show are unable to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study subjects
Study subjects will be recruited for scanning in a 3T MRI scanner with dedicated high-resolution MRI sequences as stated in our research protocol.
|
Subjects will undergo MRI scanning in our 3T machine with dedicated high resolution sequences (including 2D T1-weighted inversion recovery sequences, 3D FLAIR MRI whole brain, 3D T1-weighted Sagittal MPRAGE; plus other sequences for the clinical purpose of pre-operative planning as per consensus with referring doctor)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of high resolution MRI in diagnosis
Time Frame: At the time of MRI scanning, typically 1 day
|
the sensitivity and specificity of the baseline MRI (bMRI) and the high-resolution MRI (hrMRI) studies, based on the standard of surgical findings on patients who underwent either intracranial EEG or surgical resection
|
At the time of MRI scanning, typically 1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanson Leung, MBBS (HK), Chinese University of Hong Kong
Publications and helpful links
General Publications
- Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
- Bernasconi A, Cendes F, Theodore WH, Gill RS, Koepp MJ, Hogan RE, Jackson GD, Federico P, Labate A, Vaudano AE, Blumcke I, Ryvlin P, Bernasconi N. Recommendations for the use of structural magnetic resonance imaging in the care of patients with epilepsy: A consensus report from the International League Against Epilepsy Neuroimaging Task Force. Epilepsia. 2019 Jun;60(6):1054-1068. doi: 10.1111/epi.15612. Epub 2019 May 28.
- Krumholz A, Wiebe S, Gronseth GS, Gloss DS, Sanchez AM, Kabir AA, Liferidge AT, Martello JP, Kanner AM, Shinnar S, Hopp JL, French JA. Evidence-based guideline: Management of an unprovoked first seizure in adults: Report of the Guideline Development Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2015 Apr 21;84(16):1705-13. doi: 10.1212/WNL.0000000000001487.
- Kokkinos V, Kallifatidis A, Kapsalaki EZ, Papanikolaou N, Garganis K. Thin isotropic FLAIR MR images at 1.5T increase the yield of focal cortical dysplasia transmantle sign detection in frontal lobe epilepsy. Epilepsy Res. 2017 May;132:1-7. doi: 10.1016/j.eplepsyres.2017.02.018. Epub 2017 Mar 2.
- Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.
- Hou P, Hasan KM, Sitton CW, Wolinsky JS, Narayana PA. Phase-sensitive T1 inversion recovery imaging: a time-efficient interleaved technique for improved tissue contrast in neuroimaging. AJNR Am J Neuroradiol. 2005 Jun-Jul;26(6):1432-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC 2024.133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsies, Partial
-
UCB PharmaCompleted
-
UCB PharmaCompletedPartial EpilepsiesUnited States, Poland, United Kingdom, Switzerland, Hungary, Germany, Sweden, Lithuania
-
UCB BIOSCIENCES, Inc.CompletedPartial Epilepsies | Partial Onset SeizuresUnited States
-
Institut National de la Santé Et de la Recherche...Completed
-
UCB BIOSCIENCES, Inc.CompletedPartial Epilepsies | Partial Onset SeizuresUnited States
-
UCB BIOSCIENCES, Inc.CompletedPartial EpilepsiesUnited States
-
UCB PharmaCompletedPartial EpilepsiesUnited States, Austria, Bulgaria, Czechia, Denmark, Finland, France, Greece, Italy, Mexico, Romania, Russian Federation, Spain, Switzerland, Turkey
-
Ono Pharmaceutical Co., Ltd.Recruiting
-
Vertex Pharmaceuticals IncorporatedTerminatedEpilepsyUnited States, Germany
-
Bial - Portela C S.A.Completed
Clinical Trials on Magnetic Resonance Imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Stanford UniversityTerminatedLaryngeal Neoplasms | Head and Neck Cancers | Larynx CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy SubjectUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Chinese University of Hong KongBeijing Tiantan HospitalRecruitingStroke | Brain Diseases | Ischemic Stroke | Stroke, Ischemic | Stroke, Acute | Stroke Hemorrhagic | Intracerebral Hemorrhage | Stroke (CVA) or TIAHong Kong
-
University of WarwickNorthern Care Alliance NHS Foundation Trust; University Hospitals Coventry... and other collaboratorsUnknown
-
Daniel M. SpielmanNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedMalignant Central Nervous System Neoplasm | Metastatic Malignant Neoplasm in the Central Nervous SystemUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedBrain TumorUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedThoracic Spine NeoplasmUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)Terminated