NCT00468078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

April 30, 2007

Last Update Submit

January 11, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseEssential tremorF-18 FPCITPET

Outcome Measures

Primary Outcomes (1)

  • diagnostic sensitivity and specificity, and acute complication

    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)

    10 days

Study Arms (2)

A

EXPERIMENTAL

Parkinson's disease

Procedure: PET/CTDrug: F-18 FPCIT

B

ACTIVE COMPARATOR

ET+Normal

Procedure: PET/CTDrug: F-18 FPCIT

Interventions

PET/CTPROCEDURE

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

Also known as: Positron Emission Tomography
AB
F-18 FPCITDRUG

5mCi, intravenous injection

AB

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related 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.

    PMID: 9744335BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseEssential Tremor

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jae Seung Kim, MD

    Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 1, 2007

Study Start

November 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

KR(1)