Clinical trial · Interventional
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
NCT05965817CI-TRIAL-00076963FOCUS GREENunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Image | — | UNRESOLVED | — |
| Liver Metastasis Colon Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGM-101 op top of ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with colorectal liver metastases receiving SGM-101 and ICG
- description
- In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and receive SGM-101 and ICG
- interventionNames
- Drug: SGM-101 op top of ICG
Primary outcomes (1)
- measure
- To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.
- timeFrame
- 1.5 years
- description
- 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' 2. A positive score on the patient's experience measured with survey B 'patient experience'. 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 4. No cross-interference of fluorescent signal of both dyes within the two different excitation and emission channels. Feasibility is reached when a positive result on all four items is scored.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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:
1. Scheduled for surgical resection of \>3 CRLM or;
2. completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or;
3. 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:
* 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
1. History of any anaphylactic shock;
2. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
3. 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;
4. Previous administration of SGM-101
2. Patients with contraindications for Indocyanine green:
1. Allergy for shells and/or clamps
2. Hyperthyroidism
3. Known allergy for ICG
3. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectivesReferences
Publications (0)
Data not yet available
No reference posted for this study.