A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
研究概览
简要总结
This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors.
The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). Subjects must have completed all recommended adjuvant radiotherapy. Subjects who continue on systemic therapy may be included at the discretion of the treating physician.
- •Subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion.
- •Subjects taking hormonal therapy are eligible for inclusion
- •Subject has any stage lymphedema
排除标准
- •Active rash or skin tears/injury in bilateral upper extremities
- •Subjects with history of contralateral breast cancer treatment
研究组 & 干预措施
CSI ultrasound measurement
Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.
干预措施: Constructive Shearwave Interference (CSI) (Device)
结局指标
主要结局
Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
时间窗: baseline
differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb
次要结局
未报告次要终点