Back to resultsEvaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tomosynthesis digital mammography imaging system
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, digital mammography, tomosynthesis
Eligibility Criteria
Inclusion Criteria:
- Female
- Any ethnic origin
- No contraindication for screening mammography
Exclusion Criteria:
- Significant breast trauma
- Pregnancy
- Lactating
- Breast implants
- Previous breast cancer
- Previous surgical biopsy
- Placement of an internal breast marker
- Unable to understand and or execute written informed consent
Sites / Locations
- Yale New Haven Hospital
- University of Iowa Medical Center
- Massachusetts General Hospital
- Dartmouth Hitchcock Medical Center
- Magee Women's Hospital
Outcomes
Primary Outcome Measures
To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
Secondary Outcome Measures
To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00754598
Brief Title
Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Official Title
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hologic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.
The resulting images from the this portion of the study were then randomized into a reader study.
The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:
Reduce the recall rate And/or
Improve ROC area due to improved breast cancer detection and/or improved lesion classification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, digital mammography, tomosynthesis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
1183 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Tomosynthesis digital mammography imaging system
Other Intervention Name(s)
Genesis, Hologic Tomosynthesis, Tomo
Intervention Description
a full-field digital mammography system where multiple images are acquired at various angles near the normal to the detector. Breast compression is performed in a standard geometry. The acquired images are reconstructed using mathematical algorithms, not unlike CT reconstructions, to generate a set of thin slices parallel to the breast platform. The reconstructed slices can be viewed individually or in a movie format.
Primary Outcome Measure Information:
Title
To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
Time Frame
10-12 months
Secondary Outcome Measure Information:
Title
To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images.
Time Frame
10-12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Any ethnic origin
No contraindication for screening mammography
Exclusion Criteria:
Significant breast trauma
Pregnancy
Lactating
Breast implants
Previous breast cancer
Previous surgical biopsy
Placement of an internal breast marker
Unable to understand and or execute written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rafferty, M.D
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Iowa Medical Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
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