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
Inclusion Criteria7
- 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 Criteria11
- 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
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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