Analyzing brain imaging biomarkers in patients with cerebral cavernous malformation-related epilepsy
Quantitative Susceptibility Mapping Biomarker, Brain Structure and Connectome Associated With Cerebral Cavernous Malformation Related Epilepsy and Outcome After Surgery
This study is trying to see if brain scans can help find signs of iron buildup in people with cerebral cavernous malformation and epilepsy, which could improve how we manage their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT04076449 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with cerebral cavernous malformation (CCM) and related epilepsy (CRE). It employs quantitative susceptibility mapping (QSM) to assess iron deposition in the brain, which may contribute to epilepsy. Participants will undergo annual clinical evaluations, including video EEG recordings and MRI studies, over a five-year follow-up period. The study aims to identify biomarkers that predict the risk of CRE and improve management strategies for patients with CCM.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with a single cerebral cavernous malformation and no prior treatment of the symptomatic lesion.
Not a fit: Patients with multiple brain lesions, a history of previous intracranial surgery, or other progressive neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies and improved outcomes for patients with cerebral cavernous malformation-related epilepsy.
How similar studies have performed: While the approach of using quantitative susceptibility mapping is innovative, similar studies have shown promise in understanding brain conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Peking University International Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Li Ma, MD, PhD — Beijing Tiantan Hospital
- Study coordinator: Li Ma, MD, PhD
- Email: marygl@hotmail.com
- Phone: 86-010-59978317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.