Efficacy and Safety of F-18 FPCIT PET in Parkinson's Dise... | NCT00468078

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

NCT00468078

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 13, 2016Estimated

Enrollment

78Actual

Phase

Phase 3

Conditions

Parkinson's Disease

Interventions

PET/CT
F-18 FPCIT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Apr 30, 2007

First Submission Date that Met QC Criteria

Apr 30, 2007

First Posted Date

May 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Parkinson's disease	Procedure: PET/CT Drug: F-18 FPCIT
B	Active Comparator	ET+Normal	Procedure: PET/CT Drug: F-18 FPCIT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Procedure	10min acquisition, 90min after injection of F-18 FPCIT	A B

Measure	Description	Time Frame
diagnostic sensitivity and specificity, and acute complication		1 month

Measure	Description	Time Frame
correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)		10 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jae Seung Kim, MD	Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9744335	Background	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.

ID	Term
D010300	Parkinson Disease
D020329	Essential Tremor

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques