Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|