Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

Not Applicable

Recruiting

• Conditions: Esophageal Carcinoma; Gastric Carcinoma
• Interventions: Drug: Indocyanine Green (IC-Green); Diagnostic Test: Fluorescence guided identification using indocyanine green

• Registration Number: NCT07108855
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Start: 2025-09-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;
• Age of 18 years or older;
• Able to provide written informed consent.

Exclusion Criteria (contraindications for indocyanine green):

• Known allergy to indocyanine green;

• Known allergies to iodine, shellfish and/or clams;

• eGFR < 30 mL/min/1.73 m2;

• Pregnancy or breastfeeding;

• Hyperthyroidism.

  • Severe liver disease (ascites and cirrhosis).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systemic administration of ICG	Indocyanine Green (IC-Green)	Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure.
Systemic administration of ICG	Fluorescence guided identification using indocyanine green	Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure.

Primary Outcome Measures

Name	Time	Method
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD	After study completion, to be expected within 8 months	Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.

Secondary Outcome Measures

Name	Time	Method
Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME	One week after the qFME procedure	Visibility is determined visual evaluation during the endoscopic procedure and calculating the TBR in the same manner as explained above.

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands