Indocyanine green to highlight tumor depth and margins during endoscopic removal of esophageal or stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will receive a systemic injection of indocyanine green (ICG) and undergo near-infrared quantified fluorescence molecular endoscopy (qFME) during endoscopic submucosal dissection (ESD) to visualize tumor margins and invasion depth. Fluorescence imaging findings will be compared with standard white-light endoscopy and pathology from resected specimens to determine concordance with true tumor demarcation and depth. This is a phase 1/2, single-center feasibility trial at University Medical Center Groningen enrolling adults with confirmed superficial (T1) esophageal or gastric adenocarcinoma scheduled for ESD. The study will collect safety data, image quality metrics, and preliminary diagnostic accuracy to inform further development.

Why it matters

Who can join: the full rules

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).

Where it's running

• University Medical Centre Groningen
  Groningen, Provincie Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Wouter B. Nagengast, MD, PharmD, PhD
• Email: w.b.nagengast@umcg.nl
• Phone: +31(0)503612620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.