Overview

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

Status:
Recruiting

Trial end date:
2025-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Leiden University Medical Center

Criteria

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