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Trial record 1 of 1 for:    NCT00535327
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Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535327
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
September 24, 2007
September 26, 2007
May 14, 2010
August 2007
March 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00535327 on ClinicalTrials.gov Archive Site
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Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography
A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography
Comparison of the ability of DBT and FFDM to detect breast cancer.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Women referred for diagnostic mammogram
Breast Cancer
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
  • Able and willing to comply with study procedures, and have signed and dated the informed consent form
  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00535327
GE 190-002
No
Not Provided
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GE Healthcare - Kevin Horgan, GE Healthcare
GE Healthcare
Not Provided
Study Director: Amy Longcore GE Healthcare
GE Healthcare
May 2010