Development and Clinical Application of [11C]Verapamil-PET

Phase 2

• Conditions: Epilepsy
• Interventions: Drug: [11C] -verapamil PET

• Registration Number: NCT02144792
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-04-22
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-22
• Last Update Posted: 2014-05-22
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy controls ( age range 20-45 years)
• Patient age (> 15), diagnose as epilepsy

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Exclusion Criteria

• Subjects who take medicines that affect on the function of p-glycoproteins
• Pregnancy or subject who feed the breast milk
• Subjects who had severe renal disease or liver disease
• Subjects who need treated by immunosuppressant or take immunosuppressant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group (healthy persons)	[11C] -verapamil PET	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.
Patients with drug-resistant epilesy	[11C] -verapamil PET	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.
Patients with drug-sensitive epilepsy	[11C] -verapamil PET	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.

Primary Outcome Measures

Name	Time	Method
Measured Asymmetric index[(SUV in Right regions - SUV in Left regions)/(SUV in Right regions+ SUV in left regions)] in all three groups	first visit day	Comparing with Asymmetry index in each groups

Secondary Outcome Measures

Name	Time	Method
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]

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of