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| Sponsor: | Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00637598 |
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: | Case-Only, Prospective |
| Official Title: | Early Detection of Breast Cancer Using Tomosynthesis Imaging |
| Estimated Enrollment: | 350 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (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).
|
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:
Exclusion Criteria:
Subjects with any of the following conditions will be excluded from this clinical study:
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
| Responsible Party: | Duke University Health System, Duke University School of Medicine ( Joseph Lo,PhD ) |
| Study ID Numbers: | 6503, 6024 |
| Study First Received: | March 12, 2008 |
| Last Updated: | May 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00637598 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Diagnostic Imaging Mammography Breast Tomosynthesis |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |
