Digital Breast Tomosynthesis Preference Study

Study Overview
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Brief Summary
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Mammography remains the current standard in the detection of breast cancer. However, conventional two-view mammography will not detect all cancers. The major limiting factor of conventional mammography is the presence of superimposed breast tissue that can obscure clinically significant lesions. It is this limitation that decreases the sensitivity of mammography and leads to false negative results. The recent development of digital detectors has allowed imaging technologies such as tomosynthesis to become clinically feasible. The examination, similar to conventional mammography with regard to patient positioning and glandular dose, allows acquisition of a digital data set that can be reconstructed and viewed in multiple sections. The ability of tomosynthesis to unmask overlapping structures has been shown in preliminary studies to increase lesion visibility. Used as either a primary imaging modality, or as an adjunct to screening mammography, tomosynthesis has the potential to provide increased sensitivity and a lower number of false negative examinations. The purpose of this study is to compare radiologist impression of digital breast tomosynthesis to digital mammography with respect to their ability to see and characterize specific lesion features.

Official Title
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Radiologists' Preference Study - Digital Breast Tomosynthesis

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Digital Breast Tomosynthesis Exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is a woman ≥18 years of age or older who has no history of symptoms and/or physical signs of breast cancer in either breast (or, if she has had a mastectomy, in the remaining breast); The asymptomatic subject previously (within 3 months) underwent routine screening DM, which showed one or more abnormalities, and was referred for diagnostic mammography within the 30 days before study entry. The images from the screening examination must be available. If the prior screening examination was not conducted at the recruiting site, review of those images by the investigator must confirm that the recommendation for diagnostic mammography is warranted; The subject is able and willing to comply with study procedures, and has signed and dated the informed consent form; The subject is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or postmenopausal (cessation of menses for more than one year); or, if of childbearing potential, the possibility of pregnancy is remote based on a negative patient history or a negative urine pregnancy test. Exclusion Criteria: The subject is pregnant or trying to become pregnant; The subject has been previously included in this study; The subject has a history of any symptoms and/or physical signs of breast cancer in either breast (or if she has had a mastectomy, no signs or symptoms of breast cancer in the remaining breast); The subject has breasts too large to be adequately positioned on 19 x 23 centimeter (cm) FFDM digital receptor without anatomical cut off during a DBT examination; The subject has participated in any of the on-going GE studies (GE 190-001, GE 190-002 or GE 190-003), or is participating in, or has participated in (within the prior 30 days), another trial of an investigational product; Has breast implant(s). Has reconstructed breast(s).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All enrolled subjects will undergo digital breast tomosynthesis. | Device: Digital Breast Tomosynthesis Exam<br>* Digital Breast Tomosynthesis Exam consisting of single view (MLO) of each breast will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reader Preference |  | upon recruitment/enrollment phase completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, 3D Digital Mammography, Digital Breast Tomosynthesis