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

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help surgeons remove liver tumors that have spread from colorectal cancer. The trial is looking at using two special dyes, SGM-101 and Indocyanine Green (ICG), to help doctors see the tumors more clearly during surgery. This is the first time these two dyes will be used together in patients, and they hope to learn if this approach can make the surgery safer and more effective. The trial is currently looking for 10 patients aged 18 and older who have liver tumors from colorectal cancer and are scheduled for surgery.

To be eligible for this trial, patients must have liver metastases (tumors that started in the colon or rectum and spread to the liver) and should be planning to have surgery to remove these tumors. They should also be generally healthy and able to give consent to participate. However, people with certain allergies, serious infections, or specific health conditions may not be able to take part. If someone joins the trial, they can expect to have their surgery guided by these dyes, which may help the surgeon find and remove all the cancerous tissue more effectively.

Gender

ALL

Eligibility 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