This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

This study has been completed.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Thomas J. Brady, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01669148
First received: April 30, 2010
Last updated: May 19, 2017
Last verified: January 2017
  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: No masking
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

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
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

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
Study First Received: April 30, 2010
Results First Received: April 12, 2017
Last Updated: May 19, 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

ClinicalTrials.gov processed this record on June 23, 2017