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


Phase 0
30 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Breast Abnormalities

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Measure of digital tomosynthesis and digital mammography test performance.

Outcome Description:

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.

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Alexis V. Nees, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

HUM 13236

NCT ID:

NCT00722059

Start Date:

April 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Breast Abnormalities
  • Congenital Abnormalities
  • Breast Neoplasms
  • Neoplasms

Name

Location

University of Michigan Health SystemAnn Arbor, Michigan