Clinical trial NCT05613946: Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema
Official title: Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphedema Arm
Keywords: Lymphaticovenous anastomosis surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Detailed description: Part 1 - Evaluate the uptake of microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic visualization by ultrasound.

Part 2 - Combine preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. Evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Eligibility criteria: Inclusion Criteria:

* 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.31.
* 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.

Primary outcomes:
measure: Lymphatic vessel visualization
timeFrame: 5 minutes after injection
measure: High-frequency ultrasound and shear-wave elastography
timeFrame: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christine Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: