The clinical trial to evaluate the efficacy of [11C]K-2 in epilepsy patients
- Conditions
- refractory epilepsy patients
- Registration Number
- JPRN-jRCTs031180191
- Lead Sponsor
- Miyazaki Tomoyuki
- Brief Summary
In the primary endpoint, we examined the specificity of AMPA-PET in the human brain and the correlation coefficient between the amount of AMPA receptor protein expressions in the surgical specimen and AMPA receptor densities showed a high value of 0.846 or 0.891. These results sugeest that AMPA receptor densities in the living human brain can be measured with high quantitativeness by AMPA-PET. [11C]K-2PET was generally safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
1.refractory epilepsy patients(mesial temporal lobe epilepsy)
2.patinets for anterior temporal lobectomy(ATL)
3.patients who are without cerebral surgery on the same side of ATL
4.patients who are 20 years or older
5.patients who can consent to this study by oneself
1.patients who have significant abnormalities insides the brains
2.patients who have experienced the electric stimulation therapy
3.patients who undergo artificial dialysis
4.patients who have severe liver dysfunction
5.patients who have tatoo
6.claustrophobic patients
7.breast-feeding mothers, expecting mothers, females who desire to be a mother
8.patients who desire to bear a child within this study period
9.patients who take Fycompa
10.patients who underwent nuclear medicine examination within one-week before this registarion
11.patients who underwent other clinical trials using unapproved nuclear medicine examination within six month before this registarion
12.patients who underwent other clinical trials within 12 weeks before this registarion
13.patients whom study doctors consider unappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation of the AMPA receptors densities examined by biochemical study and [11C]K-2 PET study
- Secondary Outcome Measures
Name Time Method Efficacy<br>1)Engel classification and ILAE classification in evaluation of postoperative epileptic seizures<br>2)The density of AMPA receptors obtained from preoperative [11C]K-2 PET imaging, and FDG-PET values<br>3)The quantitative changes in cognitive function scores {intelligence quotient (IQ), memorial quotient (MQ)} around surgery<br>4)The quantitative changes in prescribed anti-epileptic drugs (the number of types, and the dose per day) after surgery<br>Safety<br>The adverse events occurred in patients during 7 days after PET scan