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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: [11C] -verapamil PET (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Sang Kun Lee, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Sang Kun Lee, MD, PhD, Email: sangkun2923@gmail.com

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.

Clinical Details

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

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

Primary outcome: Measured Asymmetric index[(SUV in Right regions - SUV in Left regions)/(SUV in Right regions+ SUV in left regions)] in all three groups

Secondary outcome: Number of patients with side effect of cyclosporine and [11C]-verapamil PET

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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Sang Kun Lee, MD, PhD, Email: sangkun2923@gmail.com

Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting
Sang Kun Lee, MD, PhD, Email: sangkun2923@gmail.com
Sang Kun Lee, MD, PhD, Principal Investigator
Additional Information

Starting date: May 2013
Last updated: May 19, 2014

Page last updated: August 23, 2015

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