Clinical Research Directory

Liver Function Investigation With SPECT

This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients

This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response.

RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study

Radiation segmentectomy (RS) refers to selective infusion of Y-90 microspheres to the tumor bearing hepatic segment of hepatic artery. Majority of the data on RS is based on the Glass microspheres experience. Due to different properties of Resin and Glass microspheres description of dose limits to the segment for effectiveness of treatments with Resin microspheres are needed. Based on this background in this study it is aimed to evaluate the safety and efficacy of RS with resin microspheres in HCC patients. Secondly, it is planned to describe the dose limits for complete radiological response.

An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer

Transarterial radioembolization (TARE) is a key treatment option for patients with unresectable hepatocellular carcinoma (HCC), a primary form of liver cancer. TARE is a minimally invasive therapy in which radioactive microspheres are delivered through a microcatheter near the tumour into the liver's blood vessels. Although TARE can significantly improve survival, treatment outcomes remain variable and difficult to predict, mainly because of complex liver vasculature and unpredictable distribution of radioactive microspheres due to uncertain parameters such as catheter tip location, catheter orientation, and injection velocity. The long-term goal would be to make these treatments more predictable and effective by developing a patient-specific pre-treatment planning platform. Blood flow and microsphere transport will be modelled in a digital model of the patient-specific hepatic arterial tree (based on clinical imaging) using computational fluid dynamics (CFD), in combination with Monte Carlo-based radiation dosimetry. Using CFD simulations, we will investigate how variations in treatment parameters influence the microsphere distribution, aiming to better understand their role in treatment variability. This will allow us to predict the dose distribution of a certain treatment and determine potentially a more optimal set of treatment parameters. This research contributes to the broader field of cancer research by laying the foundations for a digital tool for personalized pre-treatment planning. The insights gained could support interventional radiologists in optimizing treatment planning, improving tumor targeting, and minimizing radiation exposure to healthy liver tissue in future TARE procedures.

NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC

This prospective, single-arm exploratory study evaluates the feasibility and safety of a novel ICG-Cisplatin self-assembled nanoprobe (NIR-II NanoM) for fluorescence-guided surgery in patients with Hepatocellular Carcinoma (HCC). Participants will receive a transarterial injection of the nanoprobe mixed with lipiodol prior to surgery. During the subsequent laparoscopic anatomic hepatectomy, surgeons will utilize a Near-Infrared II (NIR-II) imaging system to visualize tumor boundaries and liver segments for precise resection.

T-Cell Therapy (ECT204) in Adults With Advanced HCC

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.

15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial

The goal of this clinical trial is to evaluate the safety of two durations of the Pringle maneuver in adults undergoing elective liver resection for malignant tumors. The main questions it aims to answer are: Is the incidence of post-hepatectomy liver failure different between 15-minute and 45-minute Pringle maneuver durations? * Do the durations differ in operative time or intraoperative blood loss? * Researchers will compare patients randomized 1:1 to 15 minutes vs 45 minutes of Pringle clamping to see if outcomes are non-inferior between groups. Participants will: * Undergo standard oncologic hepatectomy with the assigned Pringle duration. * Receive routine perioperative assessments, including laboratory tests and clinical evaluations. * Attend follow-up visits at approximately 6 months, 1 year, and 3 years after surgery.

International Study on Treatment of Liver (HCC) Patients With IRE

Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation

International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE

Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.

To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients

This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation only. The main questions it aims to answer are: Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver cancer? Does the intervention improve liver metabolism?

Digital Early Warning System for Acute Lung Injury in Liver Surgery

This study focuses on developing an explainable machine learning model based on cardiopulmonary interaction characteristics to achieve early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will establish a digital early-warning system for ALI to provide support for clinical diagnosis and treatment decisions, thereby reducing the incidence and fatality rate of ALI.

The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/Contrast-enhanced MRI in Malignant Liver Lesions

Liver disease, a major global health burden, ranges from mild dysfunction to severe conditions like cirrhosis and hepatocellular carcinoma (HCC), the fifth most common cancer. Accurate diagnosis of liver lesions-distinguishing benign from malignant-is vital for treatment planning. Conventional imaging (ultrasound, CT, MRI) has limitations in sensitivity and detecting small metastases. PET/CT combines metabolic and anatomical data but struggles with small lesions and cirrhotic livers. 18F-FDG PET/MRI with contrast-enhanced MRI may improve diagnostic accuracy, but its clinical benefits remain uncertain. Further research is needed to evaluate its performance, impact on patient outcomes, and cost-effectiveness in liver disease management.

AI-Driven Quantitative Decision and Surgical Planning System for Liver Cancer

This study aims to develop and validate an integrated AI-powered system for liver cancer that includes intelligent tumor boundary detection, micro-metastasis prediction, staging, treatment decision-making, and surgical planning. The system builds upon prior 3D reconstructions of liver, vessels, and bile ducts. In a retrospective multi-center, self-controlled, fully crossed multi-reader multi-case clinical trial, the researchers will compare diagnostic accuracy, staging, and planning performance between AI-assisted reads and conventional reads using CT images and pathological gold standards.

Raman Spectroscopy-Based Deep Learning Model for Early Pan-Cancer Early Diagnosis

The goal of this observational study is to explore whether a Raman-based, deep learning-assisted approach can be used to develop an effective method for early pan-cancer screening. The study includes healthy individuals, patients at risk of cancer, and patients with diagnosed cancers. The main questions it aims to answer are: * Evaluating the deep-learning model's accuracy and specificity in identifying cancer-specific features in Raman spectral data and determining whether this method can accurately classify patients based on risk. * Identifying which model is more adaptable to the Raman spectrum * Providing an interpretable analysis of the model-generated diagnosis Participants are already being diagnosed and follow-up to determine the type of cancer.

Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).

Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for: * predicting response to immune-therapeutic regimens in HCC in the early phase of treatment, * to rule out pseudo-progression, * to early predict the escape from effectiveness of treatment.

Mts105 for Advanced Hepatocellular Carcinoma

This is the first-in-human trial of MTS105 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS105 in advanced hepatocellular carcinoma.