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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00535678
First received: September 24, 2007
Last updated: May 13, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

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

Estimated Enrollment: 400
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women referred for normal screening mammogram

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535678

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

No publications provided

Responsible Party: GE Healthcare - Kevin Horgan, GE Healthcare
ClinicalTrials.gov Identifier: NCT00535678     History of Changes
Other Study ID Numbers: GE 190-001
Study First Received: September 24, 2007
Last Updated: May 13, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GE Healthcare:
Mammography
mammogram
breast
Abnormal and normal breast tissue

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

ClinicalTrials.gov processed this record on May 19, 2013