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

Launched by GE HEALTHCARE · Sep 1, 2015

Keywords

ClinConnect Summary

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 l...

Gender

FEMALE

Eligibility criteria

• 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).