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Recruiting NCT07108855

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

Phase I / Phase II Interventional Esophageal Carcinoma Gastric Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indocyanine Green (IC-Green), Fluorescence guided identification using indocyanine green.
Who it may be relevant to
Registry conditions: Esophageal Carcinoma, Gastric Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

Overview

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.

Interventions

  • Drug Indocyanine Green (IC-Green)
    Systemic administration of indocyanine green during the endoscopic procedure.
  • Diagnostic test Fluorescence guided identification using indocyanine green
    Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.

Primary outcome measures

  • Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Time frame: One week after the qFME procedure]
  • Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Time frame: One week after the qFME procedure]
  • Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Time frame: After study completion, to be expected within 8 months]
Secondary outcome measures (1)
  • Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME [Time frame: One week after the qFME procedure]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Netherlands · 1 center
  • University Medical Centre Groningen — Groningen

Identifiers

NCT: NCT07108855 · METc 2025/002 · NL88635.042.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗