Early Detection of Breast Cancer Using Tomosynthesis Imaging
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Purpose
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
| Condition | Intervention |
|---|---|
|
Breast Neoplasms |
Radiation: Mammography and tomosynthesis imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Early Detection of Breast Cancer Using Tomosynthesis Imaging |
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
|
Radiation: Mammography and tomosynthesis imaging
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
Other Names:
|
Detailed Description:
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study will be conducted at Duke University Medical Center. Approximately 350 female subjects already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy will be enrolled in this clinical study. Informed consent will be acquired by the study coordinator or attending radiologist
Inclusion Criteria:
All Subjects accepted for this clinical study must:
- Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
- Provide written informed consent
- Be able to communicate effectively with clinical study personnel.
Exclusion Criteria:
Subjects with any of the following conditions will be excluded from this clinical study:
- Childbearing potential and subject refuses serum pregnancy test or test result is positive.
Contacts and Locations| Contact: Joseph Y Lo, PhD | 919-684-7763 | joseph.lo@duke.edu |
| United States, North Carolina | |
| DUMC Mammography, Duke South Hospital, 2nd floor | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Joseph Y Lo, PhD 919-684-7763 joseph.lo@duke.edu | |
| Contact: Anne B Jarvis, RT 919-684-7883 jarvi002@mc.duke.edu | |
| Principal Investigator: | Joseph Y Lo, PhD | Duke University Health System |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00637598 History of Changes |
| Other Study ID Numbers: | Pro00013552 (6503), 6024 |
| Study First Received: | March 12, 2008 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Diagnostic Imaging Mammography Breast Tomosynthesis |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013