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A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

Primary Purpose

Parkinsonian Syndromes

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

DaTSCAN SPECT imaging

About this trial

This is an interventional treatment trial for Parkinsonian Syndromes focused on measuring Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder, Clinically uncertain Parkinsonian Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.
Onset of clinical manifestations within the last 5 years

Exclusion Criteria:

Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy
Subjects with an established/certain movement disorder clinical diagnosis
Presence of known causes of tremor

Sites / Locations

GE Healthcare
GE Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Datscan Product

Control

Arm Description

Outcomes

Primary Outcome Measures

Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.

The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.

Secondary Outcome Measures

Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.

The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.

Full Information

NCT ID

NCT00382967

First Posted

September 29, 2006

Last Updated

August 29, 2012

Sponsor

GE Healthcare

Collaborators

i3 Statprobe

1. Study Identification

Unique Protocol Identification Number

NCT00382967

Brief Title

A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

Official Title

A Multicentre, Randomised, Open Label, Comparative Phase 4 Trial to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism in a General Neurologist Setting.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

Collaborators

i3 Statprobe

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinsonian Syndromes

Keywords

Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder, Clinically uncertain Parkinsonian Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Datscan Product

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

DaTSCAN SPECT imaging

Other Intervention Name(s)

I-123 Ioflupane

Intervention Description

A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.

Primary Outcome Measure Information:

Title

Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.

Description

Time Frame

Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)

Secondary Outcome Measure Information:

Title

Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.

Description

Time Frame

From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability. Onset of clinical manifestations within the last 5 years Exclusion Criteria: Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy Subjects with an established/certain movement disorder clinical diagnosis Presence of known causes of tremor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. Andreas Kupsch

Organizational Affiliation

Virchov Klinikum, Berlin, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul Sherwin, MD

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GE Healthcare

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

GE Healthcare

City

Velizy

ZIP/Postal Code

78457

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22492213

Citation

Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.

Results Reference

derived

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A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

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