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

University Medical Center Groningen (UMCG)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Esophageal Carcinoma; Gastric Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07108855

METc 2025/002

NL88635.042.24 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Systemic administration of ICG

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green (IC-Green)

Diagnostic Test: Fluorescence guided identification using indocyanine green