UnknownPhase 2

SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia

Netherlands20 participantsStarted 2024-01-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Prior participation in this study
✕. Previous administration of SGM-101
✕. Patients with a history of anaphylactic shock
✕. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
✕. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.

What they're measuring

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

Trial details

NCT IDNCT06280690

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

Contact for this trial

Mats Warmerdam, Msc

+31715298420 m.i.warmerdam@lumc.nl

View on ClinicalTrials.gov More Colorectal Cancer trials