SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia
NCT06280690 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-02-29
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.
Conditions
- Colorectal Cancer
- Image
- Low Grade Dysplasia of Colon
Interventions
- DRUG
-
SGM-101
SGM-101 is cea-targeted fluorescent dye
Sponsors & Collaborators
-
Leiden University Medical Center
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-31
- Primary Completion
- 2025-04-30
- Completion
- 2025-07-30
Countries
- Netherlands
Study Locations
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