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Trial record 1 of 1 for:    NCT00535678
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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:
ClinicalTrials.gov Identifier:
NCT00535678
First Posted: September 26, 2007
Last Update Posted: May 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GE Healthcare
  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

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
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
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


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

Responsible Party: GE Healthcare - Kevin Horgan, GE Healthcare
ClinicalTrials.gov Identifier: NCT00535678     History of Changes
Other Study ID Numbers: GE 190-001
First Submitted: September 24, 2007
First Posted: September 26, 2007
Last Update Posted: May 14, 2010
Last Verified: April 2010

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