Indocyanine green to highlight tumor depth and margins during endoscopic removal of esophageal or stomach cancer
Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
This trial will test whether a dye called indocyanine green can help doctors see the depth and edges of superficial esophageal or stomach cancers during endoscopic submucosal dissection.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT07108855 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with confirmed superficial (T1) esophageal or gastric adenocarcinoma who are scheduled for ESD at UMCG and can provide informed consent, without contraindications to ICG, are appropriate candidates.
Not a fit: Patients with deeper (beyond T1) or metastatic tumors, known allergies to ICG/iodine/shellfish, pregnancy or breastfeeding, severe liver disease, eGFR <30 mL/min/1.73 m2, or hyperthyroidism are ineligible or unlikely to benefit.
Why it matters
Potential benefit: If successful, the technique could enable more complete tumor removal during ESD and reduce the risk of cancer recurrence.
How similar studies have performed: Several prior small studies have reported that near-infrared fluorescence endoscopy can flag upper GI tumors and aid margin detection, but broad validation for depth determination remains limited.
Eligibility criteria
Show full inclusion / 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).
Where this trial is running
Groningen, Provincie Groningen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.