An interventional study of Hologic Selenia Dimensions Digital Breast Tomosynthesis System in Breast Cancer, sponsored by Hologic, Inc.. Completed at 22 sites in United States. Open to female participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Hologic, Inc. · Not applicable, Interventional, and Screening
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 3,521 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy
Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System
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.
Also known as: Tomosynthesis, Tomo, Breast tomosynthesis, 3D Breast imaging, Selenia Dimensions, 2D plus 3D breast imaging
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.
Time frame: At time of exam
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.
Time frame: 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
Time frame: at time of exam
| Milestone | Subjects Undergoing Breast Cancer Screening |
|---|---|
| Started | 3521 |
| Completed | 3521 |
| Not completed | 0 |
ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
| Proportion | 3D + s2D | 2D FFDM |
|---|---|---|
| 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. | 0.907 (0.887 to 0.925) | 0.867 (0.810 to 0.899) |
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.
| Proportion | 3D + s2D | 2D FFDM |
|---|---|---|
| Analysis of ROC Performance in Subjects With Dense Breasts | 0.893 (0.859 to 0.929) | 0.848 (0.803 to 0.901) |
The non-cancer recall rate was measured for 3DS and 2D FFDM
| percentage of recalls | 3D + s2D | 2D FFDM |
|---|---|---|
| Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | 54.6 | 67.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Undergoing Breast Cancer Screening | — | 0/3,521 (0%) | 0/3,521 (0%) |
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.
| Age, Categorical(Participants) | Subjects Undergoing Breast Cancer Screening |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3000 |
| >=65 years | 521 |
| Sex: Female, Male(Participants) | Subjects Undergoing Breast Cancer Screening |
|---|---|
| Female | 3521 |
| Male | 0 |
| Region of Enrollment(participants) | Subjects Undergoing Breast Cancer Screening |
|---|---|
| United States | 3521 |
The record gives a start of Sep 2009, a primary completion of Sep 2011 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2025, 13 years 5 months after primary completion.
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