The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy using pathologic correlation as gold standard measure
研究概览
简要总结
Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:
- Diagnostic accuracy using pathologic correlation as gold standard measure
- Short and long term event free and overall survival
详细描述
Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.
Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:
- In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
- Prior to definitive surgical resection of the newly diagnosed malignancy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.
- •Diagnosis of primary or metastatic malignancy will be made by combination of:
- •Clinical evaluation and physical exam
- •Radiologic study including ultrasound, CT scan, and/or MRI
- •Pathologic diagnosis after biopsy
排除标准
- •Those patients and parents/guardians unwilling to provide consent/assent.
- •Pregnant and/or women who are breast feeding.
- •Patients with Iodine allergies
结局指标
主要结局
Diagnostic accuracy using pathologic correlation as gold standard measure
时间窗: 2 years
Short and long term event free and overall survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
Roshni Dasgupta
Roshni Dasgupta, MD
Children's Hospital Medical Center, Cincinnati