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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| molecular breast imaging | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| molecular breast imaging (Discovery) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. | The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. | Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Hakim, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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single group
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| ID | Title | Description |
|---|---|---|
| FG000 | Molecular Breast Imaging | molecular breast imaging (Discovery) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Women scheduled for biopsy based on a suspicious mammogram and/or ultrasound. MBI results were compared to pathology.
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| ID | Title | Description |
|---|---|---|
| BG000 | Molecular Breast Imaging | molecular breast imaging (Discovery) |
| 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 |
| 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 | Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. | The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives). | Analysis population included the number of indeterminate lesions that had negative/benign pathology results. | Posted | Number | lesions | 1 year |
|
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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 | Molecular Breast Imaging | molecular breast imaging (Discovery) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christiane Hakim | University of Pittsburgh | 412-641-1965 | chakim@magee.edu |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. | Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives). | Analysis population included the number of indeterminate lesions that had positive pathology results. | Posted | Number | lesions | 1 year |
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| 0 |
| 60 |
| 0 |
| 60 |
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