Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Tomosynthesis; Device: Conventional

• Registration Number: NCT01669148
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-04-30
• Primary Completion: 2011-06
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Study Completion: 2012-10
• Status Verified: 2017-01
• Results First Submitted: 2017-04-12
• Results First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 496

Inclusion Criteria

• Female
• 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
  • Pregnant
  • Lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomosynthesis alone	Tomosynthesis	tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
Conventional + Tomosynthesis	Conventional	conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
Conventional + Tomosynthesis	Tomosynthesis	conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.

Primary Outcome Measures

Name	Time	Method
Detection of Breast Cancer (Sensitivity)	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)

Trial Locations

Locations (1)

MGH; 🇺🇸 Boston, Massachusetts, United States