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

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468078
• Other study ID #: FPCITKR001
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2007
• Last updated: January 11, 2016
• Start date: November 2006
• Est. completion date: October 2007

Study information

• Verified date: January 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• PET/CT
10min acquisition, 90min after injection of F-18 FPCIT

Drug:
• F-18 FPCIT
5mCi, intravenous injection

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic sensitivity and specificity, and acute complication		1 month	Yes
Secondary	correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)		10 days	No