Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
NCT ID: NCT01669148
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
496 participants
INTERVENTIONAL
2007-11-30
2012-10-31
Brief Summary
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The detection of breast cancer will be increased with tomosynthesis (3D) imaging
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Conventional + Tomosynthesis
conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
Tomosynthesis
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).
Conventional
conventional (2D) imaging (standard mammography)
Tomosynthesis alone
tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
Tomosynthesis
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).
Interventions
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Tomosynthesis
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).
Conventional
conventional (2D) imaging (standard mammography)
Eligibility Criteria
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Inclusion Criteria
* Any ethnic origin
* No contraindication for routine bilateral mammography
Exclusion Criteria
* 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
35 Years
FEMALE
Yes
Sponsors
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Hologic, Inc.
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Thomas J. Brady, M.D.
Vice Chairman, Radiology Research
Principal Investigators
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Elizabeth A Rafferty, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2007p-001197
Identifier Type: -
Identifier Source: org_study_id
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