liver cancer metastases
Conditions
Interventions
Administration of SGM-101: 4 (+/-1) days prior to surgery, the patient will be
hospitalized. Written informed consent will be obtained prior to any
study-related procedure. SGM-101 administration ta
Sponsors
Chirurgie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is feasibility of the simultaneous use of ICG and SGM-101. It is deemed feasible when it meets all of the following criteria: 1. A positive score on practical workability measured with survey A *practical workability during surgery*, defined as an average score of at least neutral. 2. A positive score on the patient*s experience measured with survey B *patient experience*, defined as an average score of at least neutral. 3. SGM-101: at least 80% sensitivity, measured as follows: - For capsular lesions, that are visible in white light are counted positive if TBR >= 1.5 in vivo. - For subcapsular lesions that are not visible in white light will be counted as positive if: A: TBR >= 1.5 in vivo, OR B: TBR >= 1.5 ex vivo on whole specimen or on bread loafs All the above measurements are performed with the Quest Open Camera System 4. No cross-interference of fluorescent signal of both dyes within the two different excitation and emission channels. Cross-Interference is deemed insignificant if at macroscopic bread loaf imaging with the Quest spectrum System: A: At the 800nm channel the rim signal (ICG, 800nm) to tumour (possibly due to SGM-101, 700nm) ratio (STR) >= 1.5 B: At the 700nm channel the tumour (SGM, 700nm) to rim signal (ICG, 800nm) ratio (TRR) >= 1.5 in SGM-101 positive tumours (defined in bullet point 3). Feasibility is reached when we get a positive result on all four items. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) 1. The accuracy of ICG, SGM-101 or both to demonstrate an irradical resection. The accuracy comprises of the rate of true positives, true negatives, false positives and false negative with accompanied sensitivity, specificity, positive predictive value and negative predictive value. An irradical resection may be demonstrated by: a. A fluorescent hotspot in the wound bed of either ICG, SGM-101 or both. If this results in a reresection of the hotspot in the wound bed this is correlated to the pathology outcome. When the surgeon was not able to perform a reresection of the wound bed then the assumed corresponding site at the ex-vivo specimen will be marked to correlate it to pathology. A margin of <1mm is classified as R1. Additionally, when the surgeon performs a reresection based on white light only (SGM-101 and ICG negative), this will be noted and correlated to pathology. b. A fluorescent hotspot on the ex-vivo specimen of either ICG, SGM-101 or both. This hotspot will be marked with a stitch and correlated to pathology. Likewise, the possible reresection will be correlated to pathology. 2. Concordance rate of ICG, SGM-101, ICG and SGM-101 combined (both fluorescent) or ICG and SGM-101 combined (for which only one is fluorescent), to histopathological result (lesion benign vs malignant). The concordance rate comprises of the rate of true positives, true negatives, false positives and false negative with accompanied sensitivity, specificity, positive predictive value and negative predictive value. a. In-vivo: An in-vivo SBR (ICG)/TBR (SGM-101) of >=1,5 is determined as positive for both SGM-101 as ICG. b. ex-vivo: this will be performed with the Quest open imaging system. An ex-vivo SBR/TBR of >=1,5 is noted as positive for both SGM-101 as ICG. c. Ex-vivo bread loafs: This will be performed with both the ex-vivo Quest open imaging system as with the Pearl imaging system. A TBR/SBR of >= | — |
Countries
Netherlands
Outcome results
None listed