Status:
COMPLETED
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
Lead Sponsor:
GE Healthcare
Conditions:
Breast Cancer
Tumors, Breast
Eligibility:
FEMALE
30+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
ADAPT program consists of 2 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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2017
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02306265
Start Date
May 1 2015
End Date
July 7 2017
Last Update
January 29 2019
Active Locations (2)
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1
Beaumont Health System
Royal Oak, Michigan, United States, 48073
2
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212