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

NCT ID: NCT07108855

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Systemic administration of ICG

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.

Group Type: EXPERIMENTAL

Indocyanine Green (IC-Green)

Intervention Type: DRUG

Systemic administration of indocyanine green during the endoscopic procedure.

Fluorescence guided identification using indocyanine green

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Indocyanine Green (IC-Green)

Systemic administration of indocyanine green during the endoscopic procedure.

Intervention Type: DRUG

Fluorescence guided identification using indocyanine green

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

Intervention Type: DIAGNOSTIC_TEST

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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Wouter B. Nagengast, MD, PharmD, PhD

Role: CONTACT

w.b.nagengast@umcg.nl

+31(0)503612620

Facility Contacts

Wouter B. Nagengast, MD, PharmD, PhD

Role: primary

w.b.nagengast@umcg.nl

+31(0)503612620

Other Identifiers

NL88635.042.24

Identifier Type: OTHER

Identifier Source: secondary_id

METc 2025/002

Identifier Type: -

Identifier Source: org_study_id