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Clinical Trials/NCT01669148
NCT01669148
Completed
Not Applicable

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Massachusetts General Hospital1 site in 1 country496 target enrollmentNovember 2007
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ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Massachusetts General Hospital
Enrollment
496
Locations
1
Primary Endpoint
Detection of Breast Cancer (Sensitivity)
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Detailed Description

The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
October 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas J. Brady, M.D.

Vice Chairman, Radiology Research

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • •Any ethnic origin
  • •No contraindication for routine bilateral mammography

Exclusion Criteria

  • •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
  • •Lactating

Outcomes

Primary Outcomes

Detection of Breast Cancer (Sensitivity)

Time Frame: up to two years follow up for development of breast cancer

Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)

Study Sites (1)

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