Actively Recruiting
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
Led by Leiden University Medical Center · Updated on 2024-05-09
10
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with liver metastases from colorectal cancer and scheduled for surgical removal
- Scheduled for surgery involving more than 3 colorectal liver metastases, or
- Completed neoadjuvant chemotherapy with the last course within 3 months before surgery, or
- Scheduled for surgery due to a locally recurrent liver metastasis
- Age 18 years or older
- Willing and able to provide informed consent before study procedures
You will not qualify if you...
- History of anaphylactic shock
- Pregnancy or breastfeeding (pregnancy must be ruled out by a test within 2 weeks before study drug administration)
- Known positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody, or untreated serious infections
- Previous treatment with SGM-101
- Allergies to shellfish or clamps
- Hyperthyroidism
- Known allergy to indocyanine green (ICG)
- Any condition that may jeopardize patient safety or study objectives as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, Netherlands, 2333ZA
Actively Recruiting
Research Team
M
Mats Warmerdam, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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