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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Срок оценки: One week after the qFME procedure]
• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Срок оценки: One week after the qFME procedure]
• Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD [Срок оценки: After study completion, to be expected within 8 months]

Вторичные конечные точки (1)

• Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME [Срок оценки: One week after the qFME procedure]

Критерии участия

Критерии включения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• University Medical Centre Groningen — Groningen

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗