Focus Green: Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREE
- Conditions
- colorectal livermetastasesMedDRA version: 20.0Level: LLTClassification code: 10024700Term: Liver metastases Class: 10029104Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504615-33-00
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria: a.Scheduled for surgical resection of >3 CRLM or; b.completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or; c.Scheduled for surgery because of a locally recurrent liver metastasis., =18 years old., Willing and capable to give informed consent before study specific procedures
Patients with contraindications for SGM-101 a.History of any anaphylactic shock; b.Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate); c.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; d.Previous administration of SGM-101, Patients with contraindications for Indocyanine green: a.Allergy for shells and/or clamps b.Hyperthyroidism c.Known allergy for ICG, Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method