Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy (CRESS)
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|ClinicalTrials.gov Identifier: NCT04076449|
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : September 4, 2019
|Condition or disease|
|Cavernous Malformation, Cerebral Cavernous Angioma Cavernous Hemangioma Cavernous Hemangioma of Brain Seizures Seizures, Epileptic Epilepsy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Quantitative Susceptibility Mapping Biomarker, Brain Structure and Connectome Associated With Cerebral Cavernous Malformation Related Epilepsy and Outcome After Surgery|
|Actual Study Start Date :||September 3, 2019|
|Estimated Primary Completion Date :||December 31, 2026|
|Estimated Study Completion Date :||December 31, 2026|
Cerebral Cavernous Malformation with Epilepsy
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
Patients with cerebral cavernous malformation but without epilepsy will undergo MR imaging and be followed-up annually as our protocol defined.
- Perilesional mean QSM in CCM with conservative treatment [ Time Frame: End of study (5-year) MRI scan ]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.
- Perilesional mean QSM after surgical resection of CCM lesion [ Time Frame: End of study (3-year) MRI scan after surgery ]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.
- Ratio of seizure freedom during follow-up [ Time Frame: End of follow-up period (5-year) ]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.
- Grey matter volume in CCM with epilepsy [ Time Frame: End of study (5-year) MRI scan ]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.
- Whole-brain connectome in CCM with epilepsy [ Time Frame: End of study (5-year) MRI scan ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076449
|Contact: Li Ma, MD, PhDemail@example.com|
|Contact: Yuanli Zhao, MDfirstname.lastname@example.org|
|Beijing Tiantan Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100079|
|Contact: Li Ma, MD, PhD 86-010-59978317 email@example.com|
|Contact: Yuanli Zhao, MD 86-010-59978478 firstname.lastname@example.org|
|Sub-Investigator: Chunxue Wu, MD|
|Peking University International Hospital||Recruiting|
|Beijing, Beijing, China, 102206|
|Contact: Zongze Li, MD 86-13121226581 email@example.com|
|Principal Investigator:||Li Ma, MD, PhD||Beijing Tiantan Hospital|