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OpenTrials
Completed

NCT Number: NCT00763100

Efficacy of Tomosynthesis in the BIRADS 3 Population

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

26 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

GROUP 1

  • female of any race and ethnicity
  • 35 years or older
  • after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
  • subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
  • female of any race and ethnicity
  • 26 years or older
  • subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
  • subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
  • female of any race and ethnicity
  • 26 years or older
  • subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
  • subject will undergo study imaging within 30 days of surveillance imaging

Exclusion criteria

  • GROUP 1, 2 and 3
  • subjects unable or unwilling to participate
  • subjects who are unable or unwilling to tolerate compression
  • subjects who are pregnant or who think they may be pregnant
  • subjects who are breastfeeding

Treatment and study plan

Primary outcomes

  1. to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Collaborators

  • Hologic, Inc.

Registry information

Official study title

The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer

Acronym: BIRADS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2008
Registry last updated
Jan 6, 2011

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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