Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Outer lymphatic vessel diameter
研究概览
简要总结
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.
详细描述
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.
The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •1. Aged 18+ at the time of consent.
- •2. Confirmed breast cancer diagnosis
- •3. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
- •4. Provision of a signed and dated informed consent form.
- •5. Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •1. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
- •2. History of prior axillary nodal surgery
- •3. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
结局指标
主要结局
Outer lymphatic vessel diameter
时间窗: During ultra-high frequency ultrasound imaging
Total diameter including wall and lumen
次要结局
- Vessel wall thickness(During ultra-high frequency ultrasound imaging)
- Degree of sclerosis(During ultra-high frequency ultrasound imaging)
- Number of lymphatic channels(During ultra-high frequency ultrasound imaging)
- Channel confluence points(During ultra-high frequency ultrasound imaging)
- Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress.(From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.)
- Incidence of injection site reactions(From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.)
- Duration of injection site reactions(From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.)
- Required interventions (e.g., antibiotics) for injection site reactions(From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.)
- Quantification of the lymphatic channels identified/ visualized along linear ICG patterns(During ultra-high frequency ultrasound imaging)
- Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction)(During ultra-high frequency ultrasound imaging)
- correlation of ICG lymphography patterns and patient demographics(During ultra-high frequency ultrasound imaging)
研究者
Ara Salibian MD
Associate Professor of Surgery
University of California, Davis