NCT06280690CompletedPhase 2
SGM-T1: SGM-101 tumor targeted fluorescence endoscopy in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Oct 2024
Brief summary (registry, in English)
The main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of theCE-marked fluorescence-laparoscope of Quest Medical Imaging, to discriminate between normal, LGD and malignant tissue (HGD,T1RC) in patients with suspected T1/HGD rectal cancer. It consists of two phases for which primary objectives are defined separately: Phase I: Dose optimization phase to determine the optimal dose of SGM-101 Phase II: feasibility assessment of tumor-targeted fluorescence endoscopy with the use of SGM-101 in discriminating normal, LGDand malignant tissue (HGD, T1RC).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 7 Dec 2023
- Lead sponsor
- Academisch Ziekenhuis Leiden
- Diseases
- Colorectal cancer
- NCT number
- NCT06280690
- EU CT number
- 2024-510769-41-00
- EudraCT number
- 2023-000171-13
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior participation in this study
- Previous administration of SGM-101
Other illness
- Patients with a history of anaphylactic shock
- Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives
Other
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
Who the study is looking for
- 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.
- Age > 18 years old
- Patients should be capable and willing to give signed informed consent before study specific procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
Related publications
- CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial.Eur J Nucl Med Mol Imaging · 2026 · PMID 42690333
This page is information, not medical advice. Discuss any trial with your doctor.