Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
1 other identifier
interventional
496
1 country
1
Brief Summary
The primary hypothesis to be tested is: The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2007
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
January 1, 2017
3.6 years
April 30, 2010
April 12, 2017
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of Breast Cancer (Sensitivity)
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
up to two years follow up for development of breast cancer
Study Arms (2)
Conventional + Tomosynthesis
ACTIVE COMPARATORconventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
Tomosynthesis alone
ACTIVE COMPARATORtomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
Interventions
The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
Eligibility Criteria
You may qualify if:
- Female
- Any ethnic origin
- No contraindication for routine bilateral mammography
You may not qualify if:
- Potential subjects with any of the following will not be enrolled in the study:
- Any contraindications to mammographic screening, including, but not limited to:
- Significant existing breast trauma
- Under the age of 30 at the time of consent
- Breast Implants
- Prior Surgeries
- Unable to understand and execute written informed consent
- Pregnant
- Lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Hologic, Inc.collaborator
Study Sites (1)
MGH
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.
Results Point of Contact
- Title
- Thomas J. Brady, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A Rafferty, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chairman, Radiology Research
Study Record Dates
First Submitted
April 30, 2010
First Posted
August 20, 2012
Study Start
November 1, 2007
Primary Completion
June 1, 2011
Study Completion
October 1, 2012
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-01