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

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: F-18 FPCIT; Procedure: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT00468078

FPCITKR001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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78 participants in 2 patient groups

A

Experimental group

Description:

Parkinson's disease

Treatment:

Procedure: PET/CT

Drug: F-18 FPCIT

B

Active Comparator group

Description:

ET+Normal

Treatment:

Procedure: PET/CT

Drug: F-18 FPCIT