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

This study has been completed.
Sponsor:
Collaborator:
Futurechem Co.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00468078
First received: April 30, 2007
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Procedure: PET/CT
Drug: F-18 FPCIT
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • diagnostic sensitivity and specificity, and acute complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: November 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Parkinson's disease
Procedure: PET/CT
10min acquisition, 90min after injection of F-18 FPCIT
Other Name: Positron Emission Tomography
Drug: F-18 FPCIT
5mCi, intravenous injection
Active Comparator: B
ET+Normal
Procedure: PET/CT
10min acquisition, 90min after injection of F-18 FPCIT
Other Name: Positron Emission Tomography
Drug: F-18 FPCIT
5mCi, intravenous injection

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468078

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Futurechem Co.
Investigators
Principal Investigator: Jae Seung Kim, MD Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

Publications:
Responsible Party: Jae Seung Kim, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00468078     History of Changes
Other Study ID Numbers: FPCITKR001
Study First Received: April 30, 2007
Last Updated: February 12, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Parkinson's disease
Essential tremor
F-18 FPCIT
PET

Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014