Validation of DaTscan for Detection of Parkinson Disease... | NCT02138682

Studies
Validation of DaTscan for Detection of Parkinson Disease Related Disorders

NCT02138682

Sponsor

Wisconsin Institute for Neurologic and Sleep Disorders S.C.

Status

Unknown status

Last Update Posted

Jul 16, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Parkinson Disease
Movement Disorders

Interventions

l-123 Ioflupane

Countries

United States

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 24, 2014

First Submission Date that Met QC Criteria

May 12, 2014

First Posted Date

May 14, 2014Estimated

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

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paul Nausieda, Medical Director, Wisconsin Institute for Neurologic and Sleep Disorders S.C.Principal Investigator

Lead Sponsor

Wisconsin Institute for Neurologic and Sleep Disorders S.C.INDUSTRY

Collaborators

Name	Class
Wisconsin Parkinson Association	UNKNOWN
Medical College of Wisconsin	OTHER
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
l-123 Ioflupane		Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process.	Drug: l-123 Ioflupane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
l-123 Ioflupane	Drug	5 millicuries of Ioflupane	l-123 Ioflupane	DaTscan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Consistency Between Diagnostic Procedures	Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.	Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 75 or older
sporadic late onset Parkinson disease or one of its variants
registered in tissue donation program

Exclusion Criteria:

aged less than 75 years old
mental status preventing neuroimaging or transportation to site
inability to remain "relatively steady" during the scanning procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul A Nausieda, MD	Wisconsin Institute for Neurologic and Sleep Disorders	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical College of Wisconsin		Milwaukee	Wisconsin	53226	United States
Wisconsin Institute for Neurologic and Sleep Disorders, SC

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D009069	Movement Disorders
D004194	Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C519528	ioflupane

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided