Ultrasound Shear Wave Elastography Assessment for Staging and Surgical Management of Extremity Lymphedema

Overview

About this study

The purpose of this study is to use ultrasound shear wave elastography to stage extremity lymphedema and guide surgical management. 

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:

  • 18 years or older.
  • Biological female or male.
  • Patients scheduled with a surgical consultation with a plastic surgeon (Dr. Nho V. Tran and/or Dr. Vahe Fahradyan-Part 2).
  • Unilateral lymphedema in the upper or lower extremity (Part 2).
  • Patient must be able to come to the 6-month clinical follow-up appointment (Part 2).
  • Patients must be able to understand the study procedures and comply with them for the entire length of the study.

Exclusion Criteria: 

  • Pregnant or nursing women, as self-reported.
  • Known or suspected cardiac shunts.
  • Prior lymphedema surgery in the upper extremity.
  • Patients with documented history of congestive heart failure, nephrotic syndrome, venous insufficiency or other confounding disease.
  • Tattoo or scar on either upper extremity.
  • Patient conditions that would interfere with compliance to the study elements in the opinion of the study investigators
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent. Patient must be able to produce a written signature.
  • Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention, at the PIs discretion.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nho Tran, M.D.

Open for enrollment

Contact information:

Tiffany Bowers

(507) 266-4467

Bowers.Tiffany@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20555254

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