Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2013 |
| End Date: | January 2018 |
Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
The goal of the study is to compare the radiologist confidence level in evaluating patients
with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis
imaging device. The comparison will be made against conventional mammography acquired as a
part of a standard clinical workup. One hundred patients who are to have a clinical surgical
breast biopsy will be recruited for the study. A reader study will be performed to evaluate
the ROC characteristics of the system.
with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis
imaging device. The comparison will be made against conventional mammography acquired as a
part of a standard clinical workup. One hundred patients who are to have a clinical surgical
breast biopsy will be recruited for the study. A reader study will be performed to evaluate
the ROC characteristics of the system.
Inclusion Criteria:
- Women at least 18 years old.
- Scheduled for breast biopsy of at least one breast lesion.
- Lesion detected on mammogram.
- Symptomatic by patient self-report, patient self-breast exam or clinical exam.
- Able to provide informed consent.
Exclusion Criteria:
- Male. (It is uncommon for men to present for imaging and the overwhelming majority of
findings are non-cancerous and do not lead to biopsy; male breast cancer represents
<1% of newly diagnosed breast cancer)
- Less than 18 years of age.
- Patient unable to give consent.
- Institutionalized subject (prisoner or nursing home patient).
- Any woman who is pregnant or has reason to believe she is pregnant or any woman who is
lactating
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Yueh Z Lee, MD,PhD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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