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

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 13-008286
    Sponsor Protocol Number: 13-008286

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Katrina Glazebrook, M.B., Ch.B.

Open for enrollment

Contact information:

Tammy Drees

(507)284-1436

Drees.Tammy@mayo.edu

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CLS-20169920

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