Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07108855

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Wouter B. Nagengast, MD, PharmD, PhD

CONTACT

[email protected]

+31(0)503612620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Indocyanine Green (IC-Green)

Drug

Systemic administration of indocyanine green during the endoscopic procedure.

Fluorescence guided identification using indocyanine green

Diagnostic Test

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

Primary outcomes

  1. 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 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.

  2. 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

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

  3. 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

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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wouter B. Nagengast, MD, PharmD, PhD

CONTACT

[email protected]

+31(0)503612620

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: BRIGHT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.