Colorectal Cancer Clinical Trial
— SGM-T1Official title:
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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). | The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). | 1.5 years | |
Secondary | - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) | 1.5 years | ||
Secondary | - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope. | 1.5 years | ||
Secondary | - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo | 1.5 years | ||
Secondary | -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo | 1.5 years | ||
Secondary | - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3) | 1.5 years | ||
Secondary | - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen. | 1.5 years |
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