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

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.

Eligibility

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.

Conditions4

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