A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment - FLUOPANC-II

eids Universitair Medisch Centrum0 个研究点目标入组 40 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。

•Patienten (Part A):
•1. Signed informed consent prior to any study-mandated procedure;
•2. Patients aged over 18 years old;
•3. Has the ability to communicate well with the Investigator in the
•Dutch/English language and willing to comply with the study restrictions.
•4. Neoadjuvant treated non-primary resectable (localized) pancreatic cancer and
•scheduled for a surgical resection
•Deel B - Gezonde vrijwilligers
•1. Ondertekende geïnformeerde toestemming voorafgaand aan elke door het
•onderzoek voorgeschreven procedure;
•2. Patiënten ouder dan 18 jaar;
•3. Goed kunnen communiceren met de onderzoeker in de Nederlandse/Engelse taal.

•Patienten (Part A):
•1. History of clinically significant anaphylactic reactions;
•2. Previous use of SGM-101;
•3. Pregnant women, or women giving breast feeding;
•4. Any condition that the investigator considers to be potentially jeopardizing
•the patient*s well-being or the study objectives.
•Part B - Healthy volunteers
•1. Signed informed consent prior to any study-mandated procedure;
•2. Patients aged over 18 years old;
•3. Has the ability to communicate well with the Investigator in the
•Dutch/English language.

发起方