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A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential

NCT01885143 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2014-12-02

No results posted yet for this study

Summary

Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.

Conditions

  • Image Correction

Interventions

RADIATION

Digital Breast Tomosynthesis

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Murray Rebner, MD · Beaumont Hospital System

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01885143 on ClinicalTrials.gov