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Completed

NCT Number: NCT00826488

A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses

The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

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Key information

Conditions

Fibrocystic Disease of Breast Breast Cancer Breast Diseases Breast Neoplasms Fibrocystic Breast Disease Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

JoAnne Knight Breast Center, Barnes Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • Any race or ethnicity
  • At least 35 years old
  • Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion criteria

  • Unable or unwilling to undergo informed consent
  • Subjects who have breast implants
  • Subjects who are unable or unwilling to tolerate compression
  • Subjects who are pregnant or who think they may be pregnant
  • Subjects who are currently lactating
  • Men
  • Women less than 35 years old
  • Women greater than 80 years old
  • Subjects whose breasts are larger than the tomosynthesis detector

Treatment and study plan

Digital Breast Tomosynthesis

Device

Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.

Primary outcomes

  1. It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2009
Registry last updated
Jun 2, 2015

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.

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