Clinical trial · Interventional
SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia
SGM-101 Tumor-targeted Fluorescence Endoscopy to Enable Discrimination of Malignant From Benign Tissue in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia: a Feasibility Study
- 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 investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.
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 | — |
| Low Grade Dysplasia of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGM-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 10mg SGM-101
- description
- This cohort receives 10mg
- interventionNames
- Drug: SGM-101
- type
- EXPERIMENTAL
- label
- 5mg SGM-101
- description
- This cohort receives 5mg
- interventionNames
- Drug: SGM-101
Primary outcomes (1)
- measure
- The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).
- timeFrame
- 1.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano. 2. Age \> 18 years old 3. Patients should be capable and willing to give signed informed consent before study specific procedures. Exclusion Criteria: 1. Prior participation in this study 2. Previous administration of SGM-101 3. Patients with a history of anaphylactic shock 4. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential 5. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
M I Warmerdam, T H Dijkhuis, D J G Linders et al. · Eur J Nucl Med Mol Imaging · Sep 3, 2026 · PMID 42690333 pubmed