Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE)

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Lymphedema Arm

Treatments: Drug: Definity; Drug: Optison; Drug: Lumason

Study type: Interventional

Funder types: Other

Identifiers

NCT05613946

22-006006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Microbubble contrast agent Lumason

Other group

Description:

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Treatment:

Drug: Lumason

Microbubble contrast agent Optison

Other group

Description:

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Treatment:

Drug: Optison

Microbubble contrast agent Definity

Other group

Description:

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Treatment:

Drug: Definity