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

Stopped early · Not applicable

Conditions studied: Breast Cancer, Tumors, Breast

In brief

The aim of this recruitment plan (ADAPT-BX) 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 biopsy after recall from screening and diagnostic work-up. 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 clinical performance measures.

Key facts

Study ID

NCT02324205

Run by

GE Healthcare

People needed

196

Starts

2015-03-01

Expected to finish

2017-08-29

Last updated by the study team

2019-02-26

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged 30 years or older (≥30 years old);
• Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound (U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry;
• 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.

You may not qualify if…

• Have been previously included in this study;
• 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) FFDM digital receptor without anatomical cut off during a DBT examination (or FFDM, if required);
• 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).

Where it is running

• Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute — Boca Raton, Florida, United States
• Cooper Health - Cooper Breast Imaging Centers — Voorhees Township, New Jersey, United States
• Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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