Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

Study Overview
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Brief Summary
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The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

Detailed Description
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ADAPT-ENRICH will supplement an on-going program (ADAPT) which consists of 2 additional recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.

Official Title
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Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography ADAPT-Enrich: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy After Screening Digital Breast Tomosynthesis Exam

Conditions
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Breast Cancer, Tumors, Breast

Intervention / Treatment
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* Device: DBT and FFDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 30 years or older (≥30 years old); Initially asymptomatic women who underwent routine bilateral screening with Digital Breast Tomosynthesis (DBT), followed by diagnostic work-up showing one or more abnormalities and referred for breast biopsy; Are able and willing to comply with study procedures; Have signed and dated the informed consent form; Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy. Exclusion Criteria: Have been previously included in this study , ADAPT-SCR recruitment plan or ADAPT-BX recruitment plan; Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging; Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) DBT or FFDM digital receptor without anatomical cut-off during a DBT or FFDM examination; Have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes; Have breast implant(s); Have reconstructed breast(s).

Ages Eligible for Study
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Minimum Age: 30 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: DBT and FFDM<br>Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). | Device: DBT and FFDM<br>* Subjects underwent FFDM breast imaging followed by DBT breast imaging<br>* Other names: Full-Field Digital Mammography (2D breast imaging) FFDM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With DBT, FFDM and Biopsy Specimens Collected | For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy. | Approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Type Observed by FFDM Imaging | Lesions were characterized based on findings identified during image evaluations performed by qualified readers. | Approximately 8 weeks | 
| Lesion Type Observed by DBT Imaging | Lesions were characterized based on findings identified during image evaluations performed by qualified researchers. | Approximately 8 weeks | 
| Lesion Size as Observed by FFDM | Length of Lesions (measured in mm) when images were collected using FFDM. | Approximately 8 weeks | 
| Lesion Size as Observed by DBT | Length of lesions (measured in mm) when images were collected using DBT. | Approximately 8 weeks | 
| Biopsy Finding of Lesions | Describes histologic cancer and non-cancer findings of lesion biopsy. | Approximately 8 weeks |