Clinical trial NCT00468078: Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients
Official title: The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Essential tremor
F-18 FPCIT
PET
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.

Detailed description: Parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. Essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. F-18 FPCIT is a promising radiopharmaceutical for PET imaging to assess the dopamine transporter in the striatum.

Eligibility criteria: Inclusion Criteria:

Parkinson's disease

* Male or female with age over 40 years
* Clinical diagnosis of Parkinson's disease
* Ability to give informed consent

Essential tremor

* Male or female with age over 40 years
* Clinical diagnosis of Essential tremor
* Ability to give informed consent

Healthy volunteers

* Male or female with age over 40 years
* No any symptoms or sign suggesting Parkinson's disease or essential tremor
* Ability to give informed consent

Exclusion Criteria:

Parkinson's disease and essential tremor

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Clinical evidence of dementia
* Inability to hold antiparkinsonian medication
* History of surgical therapy for tremor
* Severe or unstable medical or psychiatric condition
* Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)
* Prior participation in other research protocol within 30 days

Healthy volunteers

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Severe or unstable medical or psychiatric condition
* Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within 6 months
* Prior participation in other research protocol within 30 days

Primary outcomes:
measure: diagnostic sensitivity and specificity, and acute complication
timeFrame: 1 month
Secondary outcomes:
measure: correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)
timeFrame: 10 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Jae Seung Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kazumata K, Dhawan V, Chaly T, Antonini A, Margouleff C, Belakhlef A, Neumeyer J, Eidelberg D. Dopamine transporter imaging with fluorine-18-FPCIT and PET. J Nucl Med. 1998 Sep;39(9):1521-30.