Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN. - SGM-101 and ICG in Colorectal Liver Metastasis

Chirurgie0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月9日

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•In total 10 patients will be included who are scheduled for resection of
•colorectal liver metastases and meet at least one of the following criteria: 1.
•Scheduled for resection of >3 CRLM or, 2. Completed neo-adjuvant
•chemotherapy, of which the last course was completed within 3 months before
•surgery or, 3. Scheduled for surgery because of a locally recurrent liver
•metastasis.

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•1. Patients with contraindications for SGM-101
•a. History of any anaphylactic shock;
•b. Patients pregnant or breastfeeding (pregnancy should be ruled out by a
•pregnancy test within two weeks prior to administration of the conjugate);
•c. Known positive test for human immunodeficiency virus (HIV), hepatitis B
•surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with
•untreated serious infections;
•d. Previous administration of SGM-101
•2. Patients with contraindications for Indocyanine green:
•a. Allergy for shells and/or clamps
•b. Hyperthyroidism
•c. Known allergy for ICG
•3. Any condition that the investigator considers to be potentially jeopardizing
•the patient*s well-being or the study objectives

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