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The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker that can quantify the expression of P-gp because of the difficulty in measuring substances in the neurologic system and the lack of clinical trials. Here, the investigators use a novel non-invasive [11C] -verapamil Brain PET and SPAM analytic method as a surrogate marker for quantifying the expression of p-glycoprotein.
A pilot study on healthy volunteers and a case-control study on patients with drug resistant epilepsy and drug sensitive epilepsy is performed. The investigators compare the whole brain SUV in each group (normal control, drug resistant epilepsy, drug sensitive epilepsy) and the asymmetry by the standardized uptake value(SUV) of ipsilateral areas and contralateral areas.
[11C] -verapamil PET will be used as a surrogate marker of P-gp expression in patients with epilepsy, and will be an important prognostic factor of individualized drug therapy. Also, it can be used as a biomarker in checking of the drug efficacy of novel medications. Furthermore, by localizing epileptogenic zones for patients, [11C] -verapamil PET could contribute in improving the prognosis of surgical treatment in drug resistant epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (healthy persons) | Active Comparator | Normal controls take a [11C] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using [11C] -verapamil, a substrate of P-gp. |
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| Patients with drug-resistant epilesy | Active Comparator | Patients with drug-resistant epilepsy take a [11C] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using [11C] -verapamil, a substrate of P-gp. |
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| Patients with drug-sensitive epilepsy | Active Comparator | Patients with drug-sensitive epilepsy take a [11C] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using [11C] -verapamil, a substrate of P-gp. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C] -verapamil PET | Drug | While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using [11C] -verapamil, a substrate of P-gp. |
| Measure | Description | Time Frame |
|---|---|---|
| Measured Asymmetric index[(SUV in Right regions - SUV in Left regions)/(SUV in Right regions+ SUV in left regions)] in all three groups | Comparing with Asymmetry index in each groups | first visit day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with side effect of cyclosporine and [11C]-verapamil PET | During and after the drug injection, During and after the PET Scan [first visit day] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Kun Lee, MD, PhD | Contact | sangkun2923@gmail.com | ||
| Jung-Won Shin, MD | Contact | limitsum@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang Kun Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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