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

Phase 2

Recruiting

• Conditions: polyp; rectal cancer; 10017990; 10017991; 10017998

• Registration Number: NL-OMON53334
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Patient must have suspected HGD/T1RC 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I/2: Primary endpoint is the ex-vivo fluorescence TDR (T1RC/HGD to LGD<br /><br>ratio).</p><br>