Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014