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

Sponsors and Collaborators:	Asan Medical Center Futurechem Co.
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00468078

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 III

Genetics Home Reference related topics: essential tremor familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Tremor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
A: Experimental Parkinson's disease	Procedure: PET/CT 10min acquisition, 90min after injection of F-18 FPCIT Drug: F-18 FPCIT 5mCi, intravenous injection
B: Active Comparator ET+Normal	Procedure: PET/CT 10min acquisition, 90min after injection of F-18 FPCIT 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

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:

Kim DW, Ahn DS, Oh YH, Lee S, Kil HS, Oh SJ, Lee SJ, Kim JS, Ryu JS, Moon DH, Chi DY. A new class of SN2 reactions catalyzed by protic solvents: Facile fluorination for isotopic labeling of diagnostic molecules. J Am Chem Soc. 2006 Dec 20;128(50):16394-7.

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.

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

Keywords provided by Asan Medical Center:

Parkinson's disease
Essential tremor
F-18 FPCIT
PET

Study placed in the following topic categories:

Essential Tremor
Ganglion Cysts
Movement Disorders
Parkinson Disease
Benign essential tremor syndrome
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Tremor

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009