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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.
The underlying goal of this study is to assess the feasibility of [18F]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]Florbetapir PET imaging | Experimental | [18F]Florbetapir and PET imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Florbetapir PET imaging | Drug | [18F]Florbetapir and PET imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Lesions Detected by [18F]Florbetapir PET | This study demonstrates the feasibility of[18F]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject. | 1 year |
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Eligibility criteria (for all subjects):
Inclusion Criteria (Healthy Volunteers):
Inclusion Criteria (MS Subjects):
Exclusion Criteria (for all subjects):
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| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Institute for Neurodegenerative Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
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| Label | URL |
|---|---|
| Institute for Neurodegenerative Disorders | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | [18F]Florbetapir Imaging | [18F]Florbetapir and PET imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [18F]Florbetapir PET Imaging | [18F]Florbetapir and PET imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Number of Lesions Detected by [18F]Florbetapir PET | This study demonstrates the feasibility of[18F]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject. | Posted | Number | Lesions | 1 year |
|
|
Adverse event data was collected for 1 year.
There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.
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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 | [18F]Florbetapir PET Imaging | [18F]Florbetapir and PET imaging | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wrist Pain | Injury, poisoning and procedural complications | Non-systematic Assessment | The pain was deemed unrelated to imaging or other study procedures. The pain was mild and not limiting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Pizarro | Invicro | 203-990-1613 | spizarro@invicro.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 19 |
| 0 |
| 19 |
| 2 |
| 19 |
|
| Chest Wall Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The adverse event was mild. The adverse event was deemed unrelated to imaging or other study procedures. The AE has been resolved. |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | Non-systematic Assessment | The adverse event was mild and deemed unrelated to imaging or other study procedures. The AE has been resolved. |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |