Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
研究概览
简要总结
This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.
详细描述
PRIMARY OBJECTIVES:
I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.
II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.
SECONDARY OBJECTIVES:
I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression
- •Mitotic rate >= 1/mm^2
- •Presence of angiolymphatic invasion
- •Deep positive margin
- •No known allergies to contrast material
排除标准
- •Pregnant or nursing
- •Patients with known cardiac shunt
- •Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
- •Patients who have experienced an acute coronary syndrome or angina in the past 6 months
- •Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
- •Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram
- •Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram
- •Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification
- •Patients with hypersensitivity to sonazoid or one of its components
- •Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
- •Patients who cannot consent for themselves
研究组 & 干预措施
Diagnostic (sonazoid, ultrasound imaging, SLNB)
Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
Diagnostic (sonazoid, ultrasound imaging, SLNB)
Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
干预措施: Ultrasonography (Device)
Diagnostic (sonazoid, ultrasound imaging, SLNB)
Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
干预措施: Sonazoid (Drug)
结局指标
主要结局
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
时间窗: Up to 1 year
Analyzed using descriptive comparison.
次要结局
未报告次要终点