Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208871
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2005-09-13
Brief Title:
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to compare within a clinical screening setting the performance of stereoscopic digital mammography with standard non-stereo digital mammography in the detection of abnormalities in the breast including early breast cancer
Detailed Description:
The clinical trial begun in December 2004 is being conducted at Emory University Over the next three years we will enroll and image about 2000 women who are at elevated risk for development of breast cancer personal or family history of breast cancer as they come in for their annual screening examinations Each participating patient will be imaged with both systems and the stereo and standard non-stereo images will be read independently by different mammographers
A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device The stereo pair of mammograms is viewed on a new third-generation high-resolution stereo display workstation that was developed in the first part of this project The mammographer views the stereo display wearing lightweight polarized glasses enabling him or her to see in depth the internal structure within the breast As a result a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image now becomes visible as the overlying and underlying normal tissue is separated in depth Conversely layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition are seen in the stereo mammogram to lie at different depths and thus will not be mistaken as a lesion
We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images We also expect that there will be fewer false positive detections with the stereo images compared to the standard images Finally we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images resulting in a reduced rate of recall of patients for further work-up
A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device The stereo pair of mammograms is viewed on a new third-generation high-resolution stereo display workstation that was developed in the first part of this project The mammographer views the stereo display wearing lightweight polarized glasses enabling him or her to see in depth the internal structure within the breast As a result a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image now becomes visible as the overlying and underlying normal tissue is separated in depth Conversely layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition are seen in the stereo mammogram to lie at different depths and thus will not be mistaken as a lesion
We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images We also expect that there will be fewer false positive detections with the stereo images compared to the standard images Finally we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images resulting in a reduced rate of recall of patients for further work-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None