RecruitingPhase 2NCT05965817
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
Sponsor
Leiden University Medical Center
Enrollment
10 participants
Start Date
Dec 1, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing two fluorescence agents — SGM-101 and indocyanine green (ICG) — to help surgeons see colorectal liver metastases (cancer that has spread from the colon to the liver) more clearly during surgery, using special light-based imaging technology. The goal is to improve how completely these tumors are removed.
**You may be eligible if...**
- You have confirmed liver metastases from colorectal cancer
- You are scheduled for surgical removal of more than 3 liver metastases, OR
- You completed chemotherapy (neoadjuvant) within the past 3 months before surgery, OR
- You are having a repeat liver surgery for recurrent disease
- You are willing and able to give informed consent
**You may NOT be eligible if...**
- You have an allergy to iodine or iodine-based contrast agents
- You are pregnant or breastfeeding
- You have serious liver dysfunction beyond what is expected from the metastases
- You are not a surgical candidate for liver resection
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGSGM-101 op top of ICG
SGM-101 op top of ICG
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05965817
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