Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Lymphatic vessel visualization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Microbubble contrast agent Lumason
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.
干预措施: Lumason (Drug)
Microbubble contrast agent Optison
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.
干预措施: Optison (Drug)
Microbubble contrast agent Definity
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.
干预措施: Definity (Drug)
结局指标
主要结局
Lymphatic vessel visualization
时间窗: 5 minutes after injection
The time from injection to lymphatic visualization, the duration of contrast visualization, and the longest length of lymphatic channel visualized for each injection site will be determined
High-frequency ultrasound and shear-wave elastography
时间窗: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
Identify any patent lymphatic channels on CEUS or high-frequency ultrasound that were not detected by the reference standard ICG lymphography. We will additionally measure dermal thickness on B-mode ultrasound and perform SWE at levels comparable to the lymphedema grading metrics routinely collected at surgical visits.
次要结局
未报告次要终点
研究者
Christine U. Lee
Principal Investigator
Mayo Clinic