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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Epilepsy

Treatments: Drug: [11C] -verapamil PET

Study type: Interventional

Funder types: Other

Identifiers

NCT02144792

0720130520

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Control group (healthy persons)

Active Comparator group

Description:

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.

Treatment:

Drug: [11C] -verapamil PET

Patients with drug-resistant epilesy

Active Comparator group

Description:

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.

Treatment:

Drug: [11C] -verapamil PET

Patients with drug-sensitive epilepsy

Active Comparator group

Description:

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.

Treatment:

Drug: [11C] -verapamil PET