An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

Study Overview
=================
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.

Official Title
-----------------
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Stereoscopic Digital Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Personal risk factors (any of the following) Personal history of breast and/or ovarian cancer, regardless of age. Prior breast biopsy that included any of the following high risk, benign lesion: Lobular carcinoma in-situ, Atypical ductal hyperplasia, Atypical lobular hyperplasia, Atypical columnar hyperplasia. Positive test for known mutations of BRCA 1 or 2 genes, regardless of age. History of chest irradiation for treatment of non-breast disease (EX:lymphoma, lung cancer) at least 15 years prior to enrollment. Family history (over 30 years of age with any of the following, some exceptions may appy) Ashkenazi Jewish ancestry, regardless of age. Any history of male breast cancer on the maternal or paternal side. Breast and ovarian cancer in a close relative (mother, sister, daughter) Breast or ovarian cancer in more than one close relative (mother,sister daughter) Breast cancer in a close relative (mother, sister, daughter) with early onset(<50 years of age) Breast and ovarian cancer in a 2nd. degree relative (grandmother, aunt, niece) with early onset of breast cancer. (<50 years of age) Multiple history of breast cancer in 1st. and 2nd. degree relatives. Exclusion Criteria: Patient does not meet any of the inclusion criteria, Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy, Patient has suspected or confirmed pregnancy, Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Stereoscopic Digital Mammography|screening digital 3D mammogram|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity/specificity |  | Aug '04 to Dec '07 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall rate |  | Aug '04 to December '7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stereoscopic digital mammography, Breast cancer detection, Reduced rate of recall, Focal abnormalities detection