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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2007

Last Updated Date

February 12, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00468078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Procedure: PET/CT
10min acquisition, 90min after injection of F-18 FPCIT

Other Name: Positron Emission Tomography
Drug: F-18 FPCIT
5mCi, intravenous injection

Study Arm (s)

Experimental: A
Parkinson's disease
Interventions:
- Procedure: PET/CT
- Drug: F-18 FPCIT
Active Comparator: B
ET+Normal
Interventions:
- Procedure: PET/CT
- Drug: F-18 FPCIT

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00468078

Other Study ID Numbers ^ICMJE

FPCITKR001

Has Data Monitoring Committee

Yes

Responsible Party

Jae Seung Kim, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Futurechem Co.

Investigators ^ICMJE

Principal Investigator:

Jae Seung Kim, MD

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

Information Provided By

Asan Medical Center

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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