Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
|ClinicalTrials.gov Identifier: NCT01773850|
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner|
|Study Type :||Observational|
|Actual Enrollment :||54 participants|
|Official Title:||Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||January 2018|
Patients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography.
Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.
Other Name: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner
- Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage) [ Time Frame: approximately 18 months ]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.
- Reader preference - arbitrary units [ Time Frame: approximately 18 months ]To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773850
|United States, North Carolina|
|The University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Yueh Z Lee, MD,PhD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Cherie M Kuzmiak, DO||University of North Carolina, Chapel Hill|