Detection of upper GI tumour depth and demarcation by quantified fluorescence molecular endoscopy using systemic administration of ICG during endoscopic submucosal dissection

Detection of upper GI tumour depth and demarcation by quantified fluorescence molecular endoscopy using systemic administration of ICG during endoscopic submucosal dissection - BRIGHT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57439

Enrollment

Registered

2025-04-15

Start date

2025-09-05

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer gastric cancer upper gastrointestinal tumours

Interventions

Intravenous administration of ICG in combination with near infrared quantified fluorescence molecular endoscopy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with confirmed high grade dysplasia or 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

Exclusion criteria: - Contraindications for indocyanine green: * Known allergy to indocyanine green * Known allergies to iodine, shells and/or clams * eGFR

Design outcomes

Primary

Measure	Time frame
The primary endpoint is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. HGD or superficial oesophageal and/or gastric adenocarcinoma (T1)) compared to healthy tissue during ESD .	—

Secondary

Measure	Time frame
Secondary endpoints include: to histopathologically determine R0 resection rate to, quantify and evaluate in vivo NIR fluorescent signals of indocyanine green (ICG) by using multi-diameter single fiber reflectance / single fiber fluorescence (MDSFR/SFF), to correlate these measurements to signal-to-background ratios based on near-infrared qFME and to explore whether the extrahepatic biliary anatomy (and the papilla of Vater) is endoscopically visible by detecting fluorescent signals with ICG-enhanced near-infared qFME.	—

Measure

Time frame

Secondary endpoints include: to histopathologically determine R0 resection rate to, quantify and evaluate in vivo NIR fluorescent signals of indocyanine green (ICG) by using multi-diameter single fiber reflectance / single fiber fluorescence (MDSFR/SFF), to correlate these measurements to signal-to-background ratios based on near-infrared qFME and to explore whether the extrahepatic biliary anatomy (and the papilla of Vater) is endoscopically visible by detecting fluorescent signals with ICG-enhanced near-infared qFME.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026