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
  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:


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 April 17, 2014