NCT04076449 Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
| NCT ID | NCT04076449 |
| Status | Recruiting |
| Phase | — |
| Sponsor | yuanli Zhao |
| Condition | Cavernous Malformation, Cerebral |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-09-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-09-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Li Ma, MD, PhD
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT04076449 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cavernous Malformation, Cerebral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04076449 currently recruiting?
Yes, NCT04076449 is actively recruiting participants. Contact the research team at marygl@hotmail.com for enrollment information.
Where is the NCT04076449 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT04076449 clinical trial?
NCT04076449 is sponsored by yuanli Zhao. The principal investigator is Li Ma, MD, PhD at Beijing Tiantan Hospital. The trial plans to enroll 200 participants.