Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
Sponsoryuanli Zhao

About this trial

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

This trial accepts healthy volunteers

Qualifiers

(1) 18 to 70 years of age

(2) Diagnosed with a single cerebral cavernous malformation

(3) No prior treatment of the symptomatic lesion

Disqualifiers

(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

Trial population

Outpatient and inpatient referred to Beijing Tiantan Hospital and Peking University International Hospital who diagnosed with cerebral cavernous malformation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Cerebral Cavernous Malformation with Epilepsy
Group B: Cerebral Cavernous Malformation without Epilepsy

Trial outcomes

Primary outcomes

1

Perilesional mean QSM in CCM with conservative treatment

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.

Time frame
End of study (5-year) MRI scan
2

Perilesional mean QSM after surgical resection of CCM lesion

Each patient contributes three outcome measurements (at year 1 and 2 and 3 after surgery). Perilesional QSM measurements will be performed at annual imaging follow-up after surgery. Mean QSM (in parts per million, ppm) in patients with or without postoperative seizure will be evaluated using univariate comparison and a repeated measures analysis implemented as an unadjusted linear mixed model.

Time frame
End of study (3-year) MRI scan after surgery
3

Ratio of seizure freedom during follow-up

Seizure freedom, defined as Engel Classification of Post-treatment Outcome Class I, will be assessed annually during follow-up period. For patients with medical treatment or conservative observation, the follow-up period begins since enrollment. For patients with surgical resection, the follow-up period begins after surgery.

Time frame
End of follow-up period (5-year)

Secondary outcomes

1

Grey matter volume in CCM with epilepsy

The presurgical grey matter volume will be calculated from three dimension T1 weighted imaging. Data of CCM with or without epilepsy will be compared and to detect the correlation between grey matter volume and seizure severity (Liverpool Seizure Severity Scale) and frequency.

Time frame
End of study (5-year) MRI scan
2

Whole-brain connectome in CCM with epilepsy

Whole-brain connectome will be reconstructed from whole-brain diffusion tensor imaging before surgical treatment. Data of CCM with or without epilepsy will be compared.

Time frame
End of study (5-year) MRI scan

Other outcomes

Sponsors and contacts

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yuanli Zhao

Lead sponsor

Beijing Tiantan Hospital

Sponsor institution

Peking University International Hospital

Collaborator