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

NCT07108855 | Recruiting Phase 1

• 2 other identifiers: METc 2025/002NL88635.042.24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma; Gastric Carcinoma

Keywords

Indocyanine Green (ICG); Fluorescence Molecular Endoscopy

Outcome Measures

Primary Outcomes (3)

• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD

  Feasibility will be assessed by analyzing the fluorescent imaging data obtained during and after the procedure. Visible fluorescence will be determined by calculating the target-to-background ratio (TBR), where the target is defined as the mean pixel intensity of the resection bed in areas displaying fluorescence.

  One week after the qFME procedure

• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD

  Secondary evaluation will focus on whether visible fluorescence after resection correlates with an R1 resection grade based on histopathology.

  One week after the qFME procedure

• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD

  Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.

  After study completion, to be expected within 8 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Systemic administration of ICG

EXPERIMENTAL

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.

Drug: Indocyanine Green (IC-Green); Diagnostic Test: Fluorescence guided identification using indocyanine green

Interventions

Indocyanine Green (IC-Green) DRUG

Systemic administration of indocyanine green during the endoscopic procedure.

Systemic administration of ICG

Fluorescence guided identification using indocyanine green DIAGNOSTIC_TEST

Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.

Systemic administration of ICG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Wouter B. Nagengast, MD, PharmD, PhD

CONTACT

+31(0)503612620; w.b.nagengast@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)