Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

May 19, 2017 updated by: Thomas J. Brady, M.D., Massachusetts General Hospital

The primary hypothesis to be tested is:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

496

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional + Tomosynthesis
conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
Device: 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).
Device: Conventional
conventional (2D) imaging (standard mammography)
Active Comparator: Tomosynthesis alone
tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to two years follow up for development of breast cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Hologic, Inc.

Investigators

  • Principal Investigator: Elizabeth A Rafferty, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007p-001197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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