- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468078
Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients (FPCIT)
January 11, 2016 updated by: Jae Seung Kim, Asan Medical Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Parkinson's disease
|
10min acquisition, 90min after injection of F-18 FPCIT
Other Names:
5mCi, intravenous injection
|
Active Comparator: B
ET+Normal
|
10min acquisition, 90min after injection of F-18 FPCIT
Other Names:
5mCi, intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diagnostic sensitivity and specificity, and acute complication
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)
Time Frame: 10 days
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jae Seung Kim, MD, Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
April 30, 2007
First Submitted That Met QC Criteria
April 30, 2007
First Posted (Estimate)
May 1, 2007
Study Record Updates
Last Update Posted (Estimate)
January 13, 2016
Last Update Submitted That Met QC Criteria
January 11, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPCITKR001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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