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
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