Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
Completed · Not applicable
Conditions studied: Breast Cancer, Tumors, Breast, Cancer Screening
In brief
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
Key facts
- Study ID
- NCT02306265
- Run by
- GE Healthcare
- People needed
- 250
- Starts
- 2015-05-01
- Expected to finish
- 2017-07-07
- Last updated by the study team
- 2019-01-29
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);
- Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
- Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility;
- Are able and willing to comply with study procedures;
- Have signed and dated the informed consent form;
- Are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).
You may not qualify if…
- Have been previously included in this study;
- Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
- Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT 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
- Beaumont Health System — Royal Oak, Michigan, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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