Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00535327
First received: September 24, 2007
Last updated: May 13, 2010
Last verified: May 2010

September 24, 2007
May 13, 2010
August 2007
March 2010   (final data collection date for primary outcome measure)
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women referred for diagnostic mammogram

Breast Cancer
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*   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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00535327
GE 190-002
No
GE Healthcare - Kevin Horgan, GE Healthcare
GE Healthcare
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Study Director: Amy Longcore GE Healthcare
GE Healthcare
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP