Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
Stopped early · Not applicable
Conditions studied: Breast Cancer, Tumors, Breast
In brief
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.
Key facts
- Study ID
- NCT02540083
- Run by
- GE Healthcare
- People needed
- 94
- Starts
- 2015-08-01
- Expected to finish
- 2017-05-30
- Last updated by the study team
- 2019-02-05
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 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.
You may not qualify if…
- 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).
Where it is running
- Carolina Breast Imaging Specialists — Greenville, North Carolina, United States
- Avera Breast Center — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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