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

NCT06280690 | Recruiting Phase 2

• 1 other identifier: NL83765.058.23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• - 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

• - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope.

  1.5 years

• - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo

  1.5 years

• -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo

  1.5 years

• - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)

  1.5 years

Study Arms (2)

10mg SGM-101

EXPERIMENTAL

This cohort receives 10mg

Drug: SGM-101

5mg SGM-101

EXPERIMENTAL

This cohort receives 5mg

Drug: SGM-101

Interventions

SGM-101 DRUG

SGM-101 is cea-targeted fluorescent dye

10mg SGM-101; 5mg SGM-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Mats Warmerdam, Msc

CONTACT

+31715298420; m.i.warmerdam@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A.L. Vahrmeijer

Model Details: This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC).

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: January 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)