Tumour-specific fluorescence-guided surgery for gastroenteropancreatic neuroendocrine neoplasms using PHT001: a phase 1, open-label, single-arm, dose-escalation study

Amsterdam UMC0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•Patients undergoing surgery for a primary GEP-NEN (stomach, duodenum, ampulla of Vater, pancreas, jejunum, ileum, colon or rectum), of any stage, grade and intent (i.e. curative/palliative) or metastases of a GEP-NEN;
•SSTR-2 positive disease, as proven by a DOTATATE PET scan pre-operatively (conducted at location AMC and part of standard care);
•Age of 18 years and older;
•Written informed consent.

•NEN, not meeting the inclusion criteria (non-GEP-NEN, unknown location);
•Pregnant or breast-feeding women;
•Known hypersensitivity to the investigational medicinal product (IMP) or any of its components;
•Patients with an allergic/infusion reaction to 1 mg of TOC test dose of the unlabelled TOC;
•Patients with known allergies to intravenous radiographic contrast agents;
•Patients who have not provided a signed informed consent form to participate in the study, prior to the start of any protocol related activities;
•Patients who, within the last 30 days, have participated in any clinical study of a therapeutic agent which may interfere with the safety or efficacy analysis of the IMP;
•Serious non-malignant disease (e.g. psychiatric infectious, autoimmune, metabolic, renal, hepatic, cardiovascular or hematological), that may interfere with the objectives of the study or with the safety of the subject, as judged by the investigator;
•A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
•A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome);
•The use of concomitant medications that prolong the QT/QTc interval.

发起方

Amsterdam UMC