NCT07108855 Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
| NCT ID | NCT07108855 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | Esophageal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07108855 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07108855 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07108855 currently recruiting?
Yes, NCT07108855 is actively recruiting participants. Contact the research team at w.b.nagengast@umcg.nl for enrollment information.
Where is the NCT07108855 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT07108855 clinical trial?
NCT07108855 is sponsored by University Medical Center Groningen. The trial plans to enroll 10 participants.