Shear Wave Elastograph and Contrast Enhanced Ultrasound for the Treatment of Lymphedema

Overview

About this study

Lymphaticovenous anstomosis is an effective surgery to treat lymphedema in the upper extremities secondary to cancer treatment. A crucial step is to identify patent lymphatic channels. Contrast enhanced ultrasound (CEUS) with intradermal injection of microbubbles is a promising method for lymphatic mapping in the upper extrmeities with lymphedema. The goals of the study are(1) to establish the preferred FDA approved microbubble agent (Lumason, Optison, Definity) for CEUS lymphatic mapping, (2) to identify lymphatic channels with CEUS and high-frequency ultrasound in patients receiving lymphaticovenous anastomosis surgery for upper extremity lymphedema, (3) and to validate the use of shear wave elastography for detecting improving in lymphedema prospectively.

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 age.
Biological female.
Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment.
Patient qualifies for LVA surgery as determined by the plastic surgeons performing the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to surgery.
Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only).
Patients must be able to understand the study procedures and comply with them for the entire length of the study.
No contraception is necessary or required.

Exclusion Criteria:

Pregnant or nursing women.
Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.
Known or suspected cardiac shunts.
Prior lymphedema surgery in the upper extremity.
Tattoo or scar on either upper extremity.
Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent..
Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

Eligibility last updated 6/24/22. 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 Christine Lee, M.D., Ph.D.	Closed for enrollment	Contact information: Breast Melanoma Oncology Research (507) 538-4849 BMSORESEARCH@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christine Lee, M.D., Ph.D.

Closed for enrollment

Contact information:

Breast Melanoma Oncology Research

(507) 538-4849

BMSORESEARCH@mayo.edu

More information

Publications

Publications are currently not available

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