The STELLAR trial: Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial
概览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration. The primary endpoint of WP-II is the number of clear resection margins
概览
简要总结
The primary aim of this study is to determine the feasibility of using intraoperative fluorescence-imaging (FLI) to identify laryngeal and hypopharyngeal cancer during total laryng(opharyng-)ectomy. A tumor-to-Background ratio (TBR) of >1.5 is defined as 'feasible'.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven squamous cell LHC, eligible for surgical resection of the tumor by TL(P)
- •≥ 18 years of age
- •Written informed consent must be obtained
- •Sufficient knowledge of the Dutch language to understand the informed consent form
排除标准
- •History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent
- •Patients with ASA classification of 4 or higher
- •Patients with measured QTc of 500 ms or higher at screening
- •Patients with laboratory abnormalities defined as: Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or AlkalinePhosphatase levels above 5 times the ULN or; Total bilirubin above 3 times the ULN or; Platelet count below 100 x 109/L or; Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males)
- •Incapacitated subjects
- •Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal or squamous cell skin carcinoma
- •Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
- •Patients with renal insufficiency (defined as eGFR<60)
- •Patients with previous kidney transplantation or a solitary functioning kidney
- •Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impairedor weakened immune system, caused by either a pre-existing disease or concomitant medications
结局指标
主要结局
The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration. The primary endpoint of WP-II is the number of clear resection margins
The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration. The primary endpoint of WP-II is the number of clear resection margins
次要结局
未报告次要终点
研究者
Principal Investigator
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)