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

Epilepsy Clinical Trial

Official title:

Development and Clinical Application of [11C]Verapamil-PET, a Surrogate Marker on P-glycoprotein Expression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144792
• Other study ID #: 0720130520
• Status: Recruiting
• Phase: Phase 2
• First received: April 22, 2014
• Last updated: May 19, 2014
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: Sang Kun Lee, MD, PhD
• Email: sangkun2923[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• [11C] -verapamil PET
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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]	Yes