N/A
N=250
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
Breast Cancer · Tumors, Breast · Cancer Screening
Bottom Line
View on ClinicalTrials.gov: NCT02306265 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Imaging Data Collected — 249; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFDM (Device); DBT (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- GE Healthcare
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Imaging Data Collected |
249; 1 | — |
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 screening mammography.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02306265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.