Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cavernous Malformation, Cerebral, Cavernous Angioma, Cavernous Hemangioma, Cavernous Hemangioma of Brain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative Susceptibility Mapping Biomarker, Brain Structure and Connectome Associated With Cerebral Cavernous Malformation Related Epilepsy and Outcome After Surgery
Overview
Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.
Detailed description
The CRESS study is a prospective observational study of imaging biomarker for cerebral cavernous malformation (CCM) related epilepsy (CRE) risk in natural history or after surgical resection. This project, funded by the National Nature Science Foundation of China, will be performed in two sites: Bejing Tiantan Hospital, Capital Medical University and Peking University International Hospital, which cover the south and north part of Beijing. Bejing Tiantan Hospital is also the China National Clinical Research Center for Neurological Diseases and the largest neurological center with high volume of patients all over the nation.
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.
Primary outcome measures
- Perilesional mean QSM in CCM with conservative treatment [Time frame: End of study (5-year) MRI scan]
- Perilesional mean QSM after surgical resection of CCM lesion [Time frame: End of study (3-year) MRI scan after surgery]
- Ratio of seizure freedom during follow-up [Time frame: End of follow-up period (5-year)]
Secondary outcome measures (2)
- Grey matter volume in CCM with epilepsy [Time frame: End of study (5-year) MRI scan]
- Whole-brain connectome in CCM with epilepsy [Time frame: End of study (5-year) MRI scan]
Eligibility criteria
Inclusion criteria
- (1) 18 to 70 years of age
- (2) Diagnosed with a single cerebral cavernous malformation
- (3) No prior treatment of the symptomatic lesion
Exclusion criteria
- (1) Associated with brain lesions and/or tumors other than CCM
- (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Beijing Tiantan Hospital, Capital Medical University — Beijing
- Peking University International Hospital — Beijing
Publications
- 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 Dec;56(12):3361-3370. doi: 10.1161/STROKEAHA.125.052339. Epub 2025 Sep 3. PMID 40899314
- 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. PMID 32951540
Identifiers
NCT: NCT04076449 · KYSQ 2018-020-01 · H0906 81801140