Clinical trial · Observational
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Quantitative Susceptibility Mapping Biomarker, Brain Structure and Connectome Associated With Cerebral Cavernous Malformation Related Epilepsy and Outcome After Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cavernous Angioma | Cavernous Hemangioma | ALIAS | 0.90 |
| Cavernous Hemangioma | Cavernous Hemangioma | ONTOLOGY_EXACT | 0.98 |
| Cavernous Hemangioma of Brain | — | UNRESOLVED | — |
| Cavernous Malformation, Cerebral | — | UNRESOLVED | — |
| Epilepsy | — | UNRESOLVED | — |
| Seizures | — | UNRESOLVED | — |
| Seizures, Epileptic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cerebral Cavernous Malformation with Epilepsy
- description
- Patients with cerebral cavernous malformation and associated with epilepsy will undergo MR imaging and be followed-up annually as our protocol defined.
- label
- Cerebral Cavernous Malformation without Epilepsy
- description
- Patients with cerebral cavernous malformation but without epilepsy will undergo MR imaging and be followed-up annually as our protocol defined.
Primary outcomes (3)
- measure
- Perilesional mean QSM in CCM with conservative treatment
- timeFrame
- End of study (5-year) MRI scan
- description
- Each patient contributes five outcome measurements (at annual image of 5-year follow-up). Perilesional QSM measurements will be performed at baseline and at annual epoch of image. Perilesional mean QSM (in parts per million, ppm) in each study group will be evaluated using univariate comparison and a repeated measures analysis implemented as an unadjusted linear mixed model.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLiu 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
- DERIVEDMa 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