Fact CheckerSign in

NCT07108855RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
30 Apr 2025
Start date
1 Sept 2025
Primary completion date
1 Jun 2027
Lead sponsor
University Medical Center Groningen
NCT number
NCT07108855

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 10
  • From 1 Sept 2025 to the primary completion date, 1 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergy to indocyanine green;
  • Known allergies to iodine, shellfish and/or clams;
  • Hyperthyroidism.
    • Severe liver disease (ascites and cirrhosis).

Lab values

  • eGFR \< 30 mL/min/1.73 m2;

Other

  • Pregnancy or breastfeeding;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Centre Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.