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Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast scanner | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Quadrants With Detected Breast Lesions | The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12). | 3 months |
| Sensitivity of iBE Breast Lesion Detection | the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection | 1 day |
| Specificity of iBE Breast Lesion Detection | the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari Brooks, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Scanner | One time use of PEFS system (Product Name: Intelligent Breast Exam™ or iBE™) on breast |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
78 participants breast scanner information was complete transferred from the iBE device
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Scanner | PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ |
| 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 | Number of Quadrants With Detected Breast Lesions | The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12). | the iBE result of each participant was broken into 4 quadrants for each breast. Some quadrants were missing iBE data. 78 participants and 342 quadrants, 77 is the number of quadrants with positive findings of the 78 participants and the 342 quadrants analyzed. | Posted | Count of Units | quadrants | 3 months | quadrants | quadrants |
|
|
1 week
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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 | Breast Scanner | PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Broach | University of Pennsylvnia | 215-662-7300 | robyn.broach@uphs.upenn.edu |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| quadrants |
|
|
| Primary | Sensitivity of iBE Breast Lesion Detection | the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection | quadrants with positive breast lesions | Posted | Count of Units | quadrants | 1 day | quadrants | quadrants |
|
|
|
| Primary | Specificity of iBE Breast Lesion Detection | the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant | breast quadrants negative for breast lesions | Posted | Count of Units | quadrants | 1 day | quadrants | quadrants |
|
|
|
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
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