Using ICG to Improve Liver Tumor Detection During Minimally Invasive Surgery
Official title: The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT06398028 · Data updated 2026-11-12
This study is testing whether a special dye can help doctors find liver tumors more easily during minimally invasive surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 173 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | August 19, 2023 |
| Main results expected | March 19, 2026 |
| Study ends | March 19, 2028 |
| Registry record updated | May 3, 2024 |
| Trial ID | NCT06398028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with liver tumors who are scheduled for minimally invasive surgery and have undergone a recent contrast-enhanced MRI.
✕Probably not a fit
Patients requiring emergency surgery or those with contraindications to ICG will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of preoperative indocyanine green (ICG) administration in enhancing the detection of liver tumors during minimally invasive liver surgery. It combines ICG fluorescence uptake with intraoperative ultrasound and preoperative MRI to improve tumor visibility. Additionally, a machine-learning algorithm will be developed to analyze photographic data for better tumor detection. The study also aims to assess the distribution of ICG in liver tissue and its relationship with liver conditions, while monitoring various clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of liver tumor detection, leading to better surgical outcomes for patients.
How similar studies have gone: Other studies have shown promising results with ICG in tumor detection, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital's multidisciplinary liver tumor board (MDTB). * Contrast enhanced MRI within 6 weeks prior to liver surgery * ≥18 years old * Absence of exclusion criteria and able to provide consent for data collection and analysis Exclusion Criteria * Emergency surgery * Patients in which ICG is contraindicated: previous history of iodine hypersensitivity, patients with renal failure (GFR \<60 mL/min/1.73 m2), uremia, clinical hyperthyroidism, autonomic thyroid adenomas, or focal and diffuse autonomic abnormalities of the thyroid gland. * Previous liver surgery.
Where it's running
-
Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Concepción Gómez Gavara
- Email: concepcion.gomez@vallhebron.cat
- Phone: 934 89 30 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.