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Focus Green: Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN
EU CTIS ID: 2023-504615-33-00
What this study is testing
To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.