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Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients (FPCIT)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PET/CT
F-18 FPCIT
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, Essential tremor, F-18 FPCIT, PET

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Parkinson's disease

ET+Normal

Outcomes

Primary Outcome Measures

diagnostic sensitivity and specificity, and acute complication

Secondary Outcome Measures

correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)

Full Information

First Posted
April 30, 2007
Last Updated
January 11, 2016
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00468078
Brief Title
Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients
Acronym
FPCIT
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Essential tremor, F-18 FPCIT, PET

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Parkinson's disease
Arm Title
B
Arm Type
Active Comparator
Arm Description
ET+Normal
Intervention Type
Procedure
Intervention Name(s)
PET/CT
Other Intervention Name(s)
Positron Emission Tomography
Intervention Description
10min acquisition, 90min after injection of F-18 FPCIT
Intervention Type
Drug
Intervention Name(s)
F-18 FPCIT
Intervention Description
5mCi, intravenous injection
Primary Outcome Measure Information:
Title
diagnostic sensitivity and specificity, and acute complication
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Seung Kim, MD
Organizational Affiliation
Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
9744335
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.
Results Reference
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Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients

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