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Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

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ClinicalTrials.gov Identifier: NCT00535678
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 14, 2010
Information provided by:
GE Healthcare

Brief Summary:
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Condition or disease
Breast Cancer

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography
Study Start Date : June 2007
Primary Completion Date : June 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women referred for normal screening mammogram

Inclusion Criteria:

  • Women ≥18 years or older for screening mammography
  • Able and willing to comply with study procedures, and have signed and dated the informed consent form
  • The subject is surgically sterile or postmenopausal

Exclusion Criteria:

  • Pregnant or trying to become pregnant
  • Has signs or symptoms of breast cancer
  • Has been previously included in this study
  • Has breast implants
  • Has a history of breast cancer and is in active treatment
  • Has breasts too large to be adequately positioned for the DBT examination

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): NCT00535678

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08844
Sponsors and Collaborators
GE Healthcare
Study Director: Amy Longcore GE Healthcare

Responsible Party: GE Healthcare - Kevin Horgan, GE Healthcare
ClinicalTrials.gov Identifier: NCT00535678     History of Changes
Other Study ID Numbers: GE 190-001
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: May 14, 2010
Last Verified: April 2010

Keywords provided by GE Healthcare:
Abnormal and normal breast tissue

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