The STELLAR trial: Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial - The STELLAR trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- 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

•- History of a clinically significant allergy or anaphylactic reactions to any
•of the components of the agent;
•- Other synchronous biopsy proven malignancies currently active, except for
•adequately treated in situ carcinomaof cervix and basal or squamous cell skin
•- Patients pregnant or breastfeeding, lack of effective contraception in male
•or female patients with reproductivepotential;
•- 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;
•- Patients using medications that may significantly impair renal function (i.e.
•NSAIDs, particularly COX-2inhibitors), that cannot be paused during the course
•of the study;
•- 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:
•o Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl
•Transferase) or AlkalinePhosphatase levels above 5 times the ULN or;
•o Total bilirubin above 3 times the ULN or;
•o Platelet count below 100 x 109/L or;
•o Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
•- Incapacitated subjects

发起方