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

yuanli Zhao

Status: Enrolling

Conditions: Seizures; Epilepsy; Cavernous Hemangioma of Brain; Cavernous Malformation, Cerebral; Cavernous Angioma; Cavernous Hemangioma; Seizures, Epileptic

Study type: Observational

Funder types: Other

Identifiers

NCT04076449

KYSQ 2018-020-01

H0906 81801140 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

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.

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.