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Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669148
First Posted: August 20, 2012
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Thomas J. Brady, M.D., Massachusetts General Hospital
  Purpose

The primary hypothesis to be tested is:

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


Condition Intervention
Breast Cancer Device: Tomosynthesis Device: Conventional

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Resource links provided by NLM:


Further study details as provided by Thomas J. Brady, M.D., Massachusetts General Hospital:

Primary Outcome Measures:
  • 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)



Enrollment: 496
Study Start Date: November 2007
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669148


Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Hologic, Inc.
Investigators
Principal Investigator: Elizabeth A Rafferty, MD Massachusetts General Hospital
  More Information

Responsible Party: Thomas J. Brady, M.D., Vice Chairman, Radiology Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01669148     History of Changes
Other Study ID Numbers: 2007p-001197
First Submitted: April 30, 2010
First Posted: August 20, 2012
Results First Submitted: April 12, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: January 2017

Keywords provided by Thomas J. Brady, M.D., Massachusetts General Hospital:
breast cancer
imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases