Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
NCT ID: NCT04076449
Last Updated: 2019-09-04
Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2019-09-03
2026-12-31
Brief Summary
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Detailed Description
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Study overview: Each participants will be followed for 5 year since enrollment. Epilepsy will be tracked with serial video EEG recordings and clinical investigations performed annually. Besides medical history of the patients, data from seizure diary and MR imaging studies (including quantitative susceptibility mapping, diffusion tensor imaging and three dimension-T1 weighted imaging), will be collected. Blood samples and tissue samples of surgical resected lesion for biomarkers studies will also be collected in all participants of the project. The data obtained in participants of CCM with or without epilepsy will be compared.
Sample size: Investigators plan to enroll 200 CCM patients in 24 months and follow up for 5 years. Based upon the preliminary results and extensive literature review, investigators predict that about 50% of participants will undergo surgical treatment, while 25% of participants remain suffering from seizure after treatment.
Study endpoints: The primary clinical endpoint of this study is a collection of a set of clinical, molecular, and MRI data in all participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cerebral Cavernous Malformation with Epilepsy
Patients with cerebral cavernous malformation and associated with epilepsy will undergo MR imaging and be followed-up annually as our protocol defined.
No interventions assigned to this group
Cerebral Cavernous Malformation without Epilepsy
Patients with cerebral cavernous malformation but without epilepsy will undergo MR imaging and be followed-up annually as our protocol defined.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* (2) Diagnosed with a single cerebral cavernous malformation
* (3) No prior treatment of the symptomatic lesion
Exclusion Criteria
* (2) History of previous intracranial surgery
* (3) Prior brain irradiation
* (4) Contraindication or unwilling or unable to undergo research MRI studies
* (5) Pregnant or breastfeeding women
* (6) Persons unable or unlikely to return for follow-up visits
* (7) Dementia or other progressive neurological disease
18 Years
70 Years
ALL
Yes
Sponsors
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Peking University International Hospital
OTHER
yuanli Zhao
OTHER
Responsible Party
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yuanli Zhao
Professor, Department of Neurosurgery
Principal Investigators
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Li Ma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu Y, Wen Z, Yuan J, Ma L, Wu C, Wu J, Liu Q, Zhang S, Wang S. Venous Architecture Predicts Hemorrhage Risk in Sporadic CCM With DVA. Stroke. 2025 Sep 3. doi: 10.1161/STROKEAHA.125.052339. Online ahead of print.
Ma L, Zhang S, Li Z, Wu CX, Wang Z, Zhan L, Hao Q, Wang H, Ye X, Chen X, Liu YO, Wang S, Zhao YL. Morbidity After Symptomatic Hemorrhage of Cerebral Cavernous Malformation: A Nomogram Approach to Risk Assessment. Stroke. 2020 Oct;51(10):2997-3006. doi: 10.1161/STROKEAHA.120.029942. Epub 2020 Sep 21.
Other Identifiers
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H0906 81801140
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KYSQ 2018-020-01
Identifier Type: -
Identifier Source: org_study_id
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