Status:
COMPLETED
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
Lead Sponsor:
Emory University
Collaborating Sponsors:
BBN Technologies
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
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 o...
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 br...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1467 Patients enrolled
Trial Details
Trial ID
NCT00208871
Start Date
December 1 2004
End Date
March 1 2011
Last Update
November 20 2013
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322