Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Females 30 years of age or older.
Dense Breasts.
Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
Suspicious or palpable mass and scheduled for biopsy.

Exclusion criteria

Pregnant or lactating women.
Prior personal history of breast cancer.
Prior breast augmentation with implants or silicon injection. male patients.
No two view mammogram as part of breast imaging evaluation.
Breast density of almost entirely fatty/scattered fibroglandular densities.

Treatment and study plan

Breast Tomosynthesis

Procedure

3D breast imaging

Primary outcomes

Measure of digital tomosynthesis and digital mammography test performance.

Time frame: 3 weeks

Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Jul 25, 2008
Registry last updated: Feb 3, 2014

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.

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

Completed