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Completed

NCT Number: NCT00468078

Efficacy and Safety of F-18 FPCIT PET 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT

Procedure

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

Other names: Positron Emission Tomography

F-18 FPCIT

Drug

5mCi, intravenous injection

Primary outcomes

  1. diagnostic sensitivity and specificity, and acute complication

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Acronym: FPCIT

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 1, 2007
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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