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Reader Study for Image Quality of Cone Beam Breast CT System

NCT02864667 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2016-08-12

No results posted yet for this study

Summary

Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.

The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.

Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.

Conditions

  • Breast Neoplasms

Sponsors & Collaborators

  • Koning Corporation

    lead INDUSTRY

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

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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 NCT02864667 on ClinicalTrials.gov