Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN.
- Conditions
- liver cancermetastases100196541002747610019818
- Registration Number
- NL-OMON53182
- Lead Sponsor
- Chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
In total 10 patients will be included who are scheduled for resection of
colorectal liver metastases and meet at least one of the following criteria: 1.
Scheduled for resection of >3 CRLM or, 2. Completed neo-adjuvant
chemotherapy, of which the last course was completed within 3 months before
surgery or, 3. Scheduled for surgery because of a locally recurrent liver
metastasis.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. 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
2. Patients with contraindications for Indocyanine green:
a. Allergy for shells and/or clamps
b. Hyperthyroidism
c. Known allergy for ICG
3. Any condition that the investigator considers to be potentially jeopardizing
the patient*s well-being or the study objectives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method