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A Study to Investigate the Performance of Dual Energy CT for the Detection of Breast Implant Rupture and Extra-capsular Silicone Compared to Standard MRI Exams.

Overview

About this study

The purpose of this study is to estimate the performance (sensitivity, specificity, accuracy) of dual energy CT for the detection of implant rupture and extracapsular silicone compared to standard multiplanar T1-, T2-weighted and silicone specific MR imaging.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion criteria:

  • Prior silicone breast implant of any type
  • Implantation longer than 12 months
  • Signed written informed consent

 

Exclusion criteria:

  • Subjects with saline-only implants
  • Pregnancy

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CLS-20169920

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