Back to resultsEarly Detection of Breast Cancer Using Tomosynthesis Imaging
Primary Purpose
Breast Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mammography and tomosynthesis imaging
Sponsored by
About this trial
This is an interventional device feasibility trial for Breast Neoplasms focused on measuring Diagnostic Imaging, Mammography, Breast Tomosynthesis
Eligibility Criteria
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.
Sites / Locations
- DUMC Mammography, Duke South Hospital, 2nd floor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tomosynthesis scans
Arm Description
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
Outcomes
Primary Outcome Measures
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637598
Brief Title
Early Detection of Breast Cancer Using Tomosynthesis Imaging
Official Title
Early Detection of Breast Cancer Using Tomosynthesis Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Diagnostic Imaging, Mammography, Breast Tomosynthesis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
385 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tomosynthesis scans
Arm Type
Experimental
Arm Description
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
Intervention Type
Radiation
Intervention Name(s)
Mammography and tomosynthesis imaging
Other Intervention Name(s)
Digital breast tomosynthesis (DBT), Breast tomosynthesis, full field digital mammography (FFDM), screen-film mammography, film-screen mammography
Intervention Description
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
Primary Outcome Measure Information:
Title
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Time Frame
at imaging review by the end of the study, approximately 9 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Y Lo, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
DUMC Mammography, Duke South Hospital, 2nd floor
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Early Detection of Breast Cancer Using Tomosynthesis Imaging
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