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The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing breast cancer screening | Other | The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hologic Selenia Dimensions Digital Breast Tomosynthesis System | Device | Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. | ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images. | At time of exam |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of ROC Performance in Subjects With Dense Breasts | The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4). Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Medical Imaging Ltd. (SMIL) | Scottsdale | Arizona | 85251 | United States | ||
| Hoag Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Undergoing Breast Cancer Screening | The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy. Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At time of exam |
| Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | The non-cancer recall rate was measured for 3DS and 2D FFDM | at time of exam |
| Newport Beach |
| California |
| 92663 |
| United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Invision/Sally Jobe | Greenwood Village | Colorado | 80111 | United States |
| Boca Raton Community Hospital | Boca Raton | Florida | 33486 | United States |
| Memorial Florida | Hollywood | Florida | 33021 | United States |
| Luthern General - Advocate Health Care | Chicago | Illinois | 60068 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Barnes Jewish | St Louis | Missouri | 63110 | United States |
| Elizabeth Wende Breast Clinic | Rochester | New York | 14620 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45912 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| York - Women's Imaging at Apple Hill | York | Pennsylvania | 17403 | United States |
| UTSW Center for Breast Care | Dallas | Texas | 75039 | United States |
| Memorial Hermann/ Memorial City | Houston | Texas | 77074 | United States |
| Intermountain Medical Imaging | Murray | Utah | 84175 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The population for this study was women undergoing breast cancer screening including those undergoing a screen mammogram or scheduled for a biopsy procedure.
The arms/groups are combined for analysis- as analysis as centered on women undergoing breast cancer screening in general and not the clinical path which made the women eligible for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Undergoing Breast Cancer Screening | The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy. Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure. |
| 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 | Participants |
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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 | To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. | ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images. | Posted | Mean | Full Range | Proportion | At time of exam |
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| Secondary | Analysis of ROC Performance in Subjects With Dense Breasts | The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4). Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference. | Posted | Mean | Full Range | Proportion | At time of exam |
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| Secondary | Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | The non-cancer recall rate was measured for 3DS and 2D FFDM | Posted | Number | percentage of recalls | at time of exam |
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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 | Subjects Undergoing Breast Cancer Screening | The population for this study was women undergoing breast cancer screening including those undergoing a screen mammogram or scheduled for a biopsy procedure. The arms/groups are combined for reporting- centered on women undergoing breast cancer screening in general and not the clinical path which made the women eligible for the study. | 0 | 3,521 | 0 | 3,521 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Bartoshevich, Sr Manager of Clinical Affairs | Hologic | 781-999-7764 | jennifer.bartoshevich@hologic.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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