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Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Elizabeth A. Rafferty, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01669148
First received: April 30, 2010
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

The primary hypothesis to be tested is:

Detection of breast cancer will be increased with tomosynthesis (3D) imaging.


Condition Intervention
Breast Cancer
 Device: Tomosynthesis
Device: standard mammography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • image quality [ Time Frame: concurrent assessment of image quality with up to two year follow up for development of breast cancer ] [ Designated as safety issue: No ]
    image quality with standard mammography vs tomosynthesis


Estimated Enrollment: 600
Study Start Date: November 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
standard mammography
 Device: standard mammography
Experimental: Arm 2
tomosynthesis
 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: standard mammography

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Elizabeth A. Rafferty, MD, Director of Breast Imaging, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01669148     History of Changes
Other Study ID Numbers: 2007p-001197
Study First Received: April 30, 2010
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
breast cancer
imaging

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

ClinicalTrials.gov processed this record on May 16, 2013