Using fluorescent dyes to improve surgery for liver metastases from colorectal cancer

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

This study is testing if using special fluorescent dyes during surgery can help doctors find and remove all cancer spots in patients with liver metastases from colorectal cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Leiden)
• Trial ID: NCT05965817 on ClinicalTrials.gov

What this trial studies

This trial investigates the feasibility of using two fluorescent dyes, SGM-101 and Indocyanine Green (ICG), during surgery for patients with colorectal liver metastases. The study aims to enhance the detection of malignant lesions that may not be visible to the naked eye, thereby improving surgical outcomes. By combining these dyes, the researchers hope to reduce the rate of R1 resections, which occur when cancerous tissue is left behind after surgery. This is particularly important for patients at high risk of incomplete resection due to factors like multiple metastases or prior treatments.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with liver metastases from colorectal cancer who are scheduled for surgical resection and meet specific high-risk criteria.

Not a fit: Patients who are not eligible include those with contraindications for SGM-101 or those who are pregnant or breastfeeding.

Why it matters

Potential benefit: If successful, this approach could lead to more complete surgical resections and improved survival rates for patients with colorectal liver metastases.

How similar studies have performed: While the use of ICG has been widely adopted and shown success in other studies, the combination with SGM-101 is novel and has not been previously tested.

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

Where this trial is running

Leiden

• Leiden University Medical Center — Leiden, Netherlands (Recruiting)

Study contacts

• Study coordinator: Mats Warmerdam, Msc

Conditions Colorectal Cancer; Liver Metastasis Colon Cancer; Image