NCT03106038已完成1 期
A Phase I/IIa Dose-escalation Study to Evaluate the Use of an Investigational Imaging Agent for the Detection of Urologic Anatomy Via Near Infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Li-Cor, Inc.
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to the initiation of study procedures
- •Are > 18 years of age
- •Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
- •Women who are expected to be admitted to the hospital following surgery for at least 24 hours
排除标准
- •Are unwilling or unable to provide informed consent.
- •Are unwilling or unable to comply with the requirements of the protocol.
- •History of prior urologic surgery.
- •History of prior pelvic surgery.
- •History of known retroperitoneal fibrosis.
- •Have any of the following screening laboratory values:
- •Hemoglobin ≤ 8.0 g/dL;
- •Absolute neutrophil count (ANC) ≤ 1500/μL;
- •Platelet count ≤ 100,000/μL;
- •Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;
- •Serum bilirubin ≥ 1.5 x IULN;
- •Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
- •Females who are pregnant, lactating, or breastfeeding;
- •Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.
研究组 & 干预措施
Nerindocianine for Injection
Experimental
One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm.
干预措施: Nerindocianine for Injection (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Events
时间窗: 30 days
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Dose response
时间窗: 10 minutes through 90 minutes post administration
Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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