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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Datscan Product | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaTSCAN SPECT imaging | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Andreas Kupsch | Virchov Klinikum, Berlin, Germany | Principal Investigator |
| Paul Sherwin, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States | ||
| GE Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22492213 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Datscan Product | [Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)]. |
| FG001 | Control Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
| Vélizy-Villacoublay |
| 78457 |
| France |
No (Injection) Intervention
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Datscan Product | [Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)]. |
| BG001 | Control Arm | No (Injection) Intervention |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Number of changes in clinical management | Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period) |
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| Secondary | 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. | The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism | Posted | Number | Number of changes in clinical management | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Datscan Product | [Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)]. | 0 | 122 | 0 | 122 | ||
| EG001 | Control Arm | No (Injection) Intervention | 0 | 137 | 0 | 137 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Igor Grachev, MD | GE Healthcare | 1-609-514-6857 | igor.grachev@ge.com |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| >=65 years |
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| Male |
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| France |
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| Denmark |
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| Germany |
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| Italy |
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| Norway |
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| Spain |
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| Switzerland |
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| United Kingdom |
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| Performance of diagnostic test not planned |
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| Avoidance of diagnostic test planned |
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| Arrangement of a referral not planned |
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| Cancellation of a referral planned |
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| Other Actions |
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| Significant changes made |
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| Participants |
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