Skip to main content
OpenTrials
Completed

NCT Number: NCT00535184

Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

Comparison of the ability of DBT and FFDM to detect breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Antisocial Personality Disorder Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Personality Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
  • 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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2007
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.