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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722059
• Other study ID #: HUM 13236
• Status: Completed
• Phase: Phase 0
• First received: July 23, 2008
• Last updated: January 31, 2014
• Start date: April 2006
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Abnormalities
• Breast Neoplasms
• Congenital Abnormalities

Intervention

Procedure:
• Breast Tomosynthesis
3D breast imaging

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of digital tomosynthesis and digital mammography test performance.	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.	3 weeks	No