Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN

Summary

This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.

Eligibility

Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  1. Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria:

     1. Scheduled for surgical resection of \>3 CRLM or;
     2. completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or;
     3. Scheduled for surgery because of a locally recurrent liver metastasis.
  2. ≥18 years old.
  3. Willing and capable to give informed consent before study specific procedures

Exclusion Criteria:

* 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

     1. History of any anaphylactic shock;
     2. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
     3. 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;
     4. Previous administration of SGM-101
  2. Patients with contraindications for Indocyanine green:

     1. Allergy for shells and/or clamps
     2. Hyperthyroidism
     3. Known allergy for ICG
  3. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives

Conditions6

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