Status:
RECRUITING
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
Lead Sponsor:
Leiden University Medical Center
Conditions:
Colorectal Cancer
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
25-30% of patients with colorectal cancer develop colorectal liver metastases (CRLM). Cornerstone for optimal survival is achieving radical surgical resections of all metastases . To assist the surgeo...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria:
- Scheduled for surgical resection of \>3 CRLM or;
- completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or;
- Scheduled for surgery because of a locally recurrent liver metastasis.
- ≥18 years old.
- Willing and capable to give informed consent before study specific procedures
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with contraindications for SGM-101
- History of any anaphylactic shock;
- Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
- 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;
- Previous administration of SGM-101
- Patients with contraindications for Indocyanine green:
- Allergy for shells and/or clamps
- Hyperthyroidism
- Known allergy for ICG
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05965817
Start Date
December 1 2023
End Date
May 1 2025
Last Update
May 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, Netherlands, 2333ZA