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Study on Indocyanine Green for Better Detection of Liver Tumors in Patients Undergoing Minimally Invasive Liver Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with liver tumors who are scheduled to undergo minimally invasive liver surgery. The study investigates the use of a medication called Indocyanine Green, which is administered before surgery. This medication is given as a powder that is mixed into a solution and injected into the bloodstream. The purpose of the study is to see if Indocyanine Green can help doctors better detect liver tumors during surgery by using a special type of light that makes the tumors glow. This technique is combined with intraoperative ultrasonography, which is a type of imaging used during surgery, and preoperative Magnetic Resonance Imaging (MRI), which is a detailed scan done before surgery.

The study aims to improve the detection of liver tumors by using a combination of these imaging techniques and the glowing effect of Indocyanine Green. Additionally, researchers are working on developing a computer program that uses machine learning to analyze photographs of the liver during surgery to help identify tumors. This program will be trained to recognize patterns in the images that indicate the presence of tumors, potentially making it easier for surgeons to find and remove them.

Participants in the study will receive the Indocyanine Green injection before their surgery. During the operation, doctors will use the special light and imaging techniques to locate the tumors. The study will help determine how effective this method is in finding liver tumors during surgery. The trial is expected to continue until early 2027, with recruitment starting in early 2024.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on specific criteria. These include having liver tumors with an indication for minimally invasive surgery, being evaluated by the hospital's multidisciplinary liver tumor board, having a contrast-enhanced MRI within 6 weeks prior to surgery, being 18 years or older, and being able to provide consent for data collection and analysis.

  2. Step 2

    Preoperative preparation

    Before surgery, the patient receives an intravenous administration of indocyanine green. This is a dye used to help detect liver tumors during surgery. The exact dosage and timing of administration are determined by the medical team.

  3. Step 3

    Surgical procedure

    During the minimally invasive liver surgery, the detection of liver tumors is enhanced using indocyanine green fluorescence. This is combined with intraoperative ultrasonography and preoperative magnetic resonance imaging to improve tumor detection.

  4. Step 4

    Data collection and analysis

    The primary goal is to quantify the intraoperative detection of liver tumors using intraoperative ultrasonography and indocyanine green. Additionally, a machine-learning algorithm is developed to detect liver tumors through photographic analysis.

Who can join the trial?

5 criteria

  • Patients must have liver tumors and need to undergo a type of surgery called minimally invasive liver surgery.
  • The decision for surgery should be evaluated by a group of specialists known as the hospital's multidisciplinary liver tumor board (MDTB).
  • Patients need to have had a special type of scan called a contrast-enhanced MRI within 6 weeks before the liver surgery. This scan helps doctors see the liver more clearly.
  • Patients must be at least 18 years old.
  • Patients should not meet any conditions that would exclude them from the study and must be able to give their permission for their data to be collected and analyzed.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing **minimally invasive liver surgery**. This means the surgery is done with small cuts and special tools, not large open surgery.
  • Patients who do not have **liver tumors**. These are abnormal growths in the liver.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Indocyanine Green is a dye used in this clinical trial to help detect liver tumors during surgery. It is administered before the operation and helps the surgeon see the tumors more clearly by making them glow under a special light. This helps improve the accuracy of the surgery by ensuring that all the tumors are found and removed.

What is already known about the treatment

Indocyanine Green – Indocyanine Green is administered intravenously and is used in imaging-guided surgery to enhance the detection of liver tumors. It is currently being studied in a phase IV clinical trial to improve the identification of liver tumors during minimally invasive liver surgery. The main therapeutic indication is for patients undergoing surgery for liver tumors. At the molecular level, Indocyanine Green works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, which helps in visualizing tumors. It is classified as a diagnostic agent used in medical imaging.

Investigated diseases

Liver Tumors – Liver tumors are abnormal growths of tissue within the liver. They can be benign, meaning non-cancerous, or malignant, which are cancerous and can spread to other parts of the body. These tumors may develop from the liver cells themselves or spread from other areas of the body. As they grow, they can interfere with liver function, potentially causing symptoms like pain, swelling, or jaundice. The progression of liver tumors varies depending on whether they are benign or malignant, with malignant tumors typically growing more rapidly. Early detection and monitoring are crucial for managing the impact on liver function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508316-27-00Protocol codeLIVERGREENEstimated enrolment173 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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