colorectal liver metastases liver metastases, colorectal cancer
Conditions
Interventions
Interventions
According to standard-of-care an infusion of 0.5mg/kg ICG will be given 7 days (+-1) before surgery. 4 days (+-1) before surgery an extra visit is planned to administer a single intraven
During surgery the Quest Spectrum camera system v2/3.0 will be used to visualize the lesions and look for additional lesions. After resection ex-vivo assessment of NIR-fluorescence will be performed b
 
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. 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 2. =18 years old 3. Willing and capable to give informed consent before study specific procedures
Exclusion criteria
Exclusion criteria: A potential participant 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 clams 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main trial endpoints The simultaneous use of ICG and SGM-101 is deemed feasible when it meets the following two criteria: 1) SGM-101 must show at least 80% sensitivity, measured as follows: Capsular lesions, that are visible in white light are only counted positive if TBR = 1.5 in vivo. Subcapsular lesions that are not visible in white light will be counted as positive if: TBR = 1.5 in vivo, OR: TBR = 1.5 ex vivo on whole specimen OR: TBR = 1.5 ex vivo on bread loafs 2) SGM must show at least 80% intra-operative NPV for all ICG visible lesions. Additionally, the percentage of cases in which SGM-101 corrects for ICG false positives by accurately distinguishing malignant from benign lesions and R0 from R1 resection margins will be assessed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary trial endpoints 1) To evaluate the number of intra-operative clinically significant events (CSEs) associated with the addition of SGM-101 to ICG. 2) Correlation of tumour composition with fluorescence signal 3) For every lesion a TBR (SGM-101) /SBR (ICG) will be calculated in vivo and ex vivo 4) The patient experience of receiving an additional infusion prior to the surgery will be measured by survey A ‘patient experience’. 5) A positive score on practical workability measured with survey B ‘practical workability during surgery’. 6) Survey C ‘surgeon’s satisfaction and judged potency’ questionnaire. 7) Determining the effect of neoadjuvant chemotherapy by measuring the difference in fluorescence signal intensity between neoadjuvant treated and non-neoadjuvant treated patients. 8) Assessment of whether the level of response after neoadjuvant chemotherapy as measured by the MRI has a significant correlation with the fluorescence signal intensity. | — |
Countries
Netherlands
Contacts
Public ContactJ.S.D. Mieog
Leids Universitair Medisch Centrum
Outcome results
None listed