Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Breast Augmentation
Withdrawn before enrolling · Not applicable
Conditions studied: Mammogram Scheduled
In brief
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with breast implants. Participants: Women with breast implants undergoing routine 2-D digital mammography. Procedures (methods): 50 female subjects with breast implants undergoing conventional screening mammography will be recruited to have a single view s-DBT in the mediolateral projection. We will perform a patient preference study and radiologist reader study composed of radiologists who have experience evaluating tomosynthesis images. A short survey will be given to each patient about their preference in modality with respect to comfort. Each reader will review the images and score the ease of interpretation, and their confidence of interpretation.
Key facts
- Study ID
- NCT02008032
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 0
- Starts
- 2013-12-01
- Expected to finish
- 2017-10-03
- Last updated by the study team
- 2018-06-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women at least 18 years old.
- Able to provide informed consent.
- History of breast augmentation mammoplasty (at least 1 year prior)
You may not qualify if…
- Male. (It is uncommon for men to present for breast imaging)
- Less than 18 years of age.
- Patient unable to give consent. Institutionalized subject (prisoner or nursing home patient).
- Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating
- Patient with a history of breast cancer (they would not be a screening exam)
- Patient with a known breast cancer (they would not be a screening study)
- Patient with a lump or nipple discharge (diagnostic population)
Where it is running
- UNC Hospital — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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