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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00468078

Acronym

FPCIT

Enrollment

Registered

2007-05-01

Start date

2006-11-30

Completion date

2007-10-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Essential tremor, F-18 FPCIT, PET

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.

Interventions

PROCEDUREPET/CT

10min acquisition, 90min after injection of F-18 FPCIT

DRUGF-18 FPCIT

5mCi, intravenous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
diagnostic sensitivity and specificity, and acute complication	1 month

Secondary

Measure	Time frame
correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)	10 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026