NCT02008032|Withdrawn
Study Stopped
No patients accrued.
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Sponsor study identifier
interventional
0
1 country
1
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 3, 2017
Actual (reported)Study Completion
October 3, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 3, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 6, 2013
Actual (reported)December 11, 2013
Actual (reported)October 3, 2017
Actual (reported)October 3, 2017
Actual (reported)Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.
18 months
Reader preference - arbitrary units
18 months
Patient preference - arbitrary units
18 months
Stationary Breast Tomosynthesis
The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UNC Hospital
Chapel Hill, North Carolina, 27599, United States
Yueh Lee, MD, PhD
University of North Carolina, Chapel Hill
0 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 3, 2017
Actual (reported)Study Completion
October 3, 2017
Actual (reported)Last Updated
June 28, 2018
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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