NCT06588569

Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors

Construction of a Multi-mode Ablation Treatment System and Molecular Imaging Multi-omics Study for Malignant Liver Tumors of Digestive System Origin

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-center, parallel-controlled clinical trial aims to establish a multi-mode ablation system for liver malignant tumors originating from the digestive system. The study will evaluate the safety and efficacy of multi-mode tumor ablation, utilizing a multi-mode imaging platform for ablation planning and immediate evaluation of intraoperative ablation effects. Additionally, the study will employ multi-omics and multi-mode imaging techniques to explore the spatiotemporal heterogeneity and immune escape mechanisms of liver metastases from gastrointestinal tumors, providing guidance for treatment strategy formulation and prognostic evaluation.

Detailed description

This is a single-center, parallel-controlled clinical trial. The study includes a total enrollment of 20 subjects. 10 patients with primary liver cancer will be divided into an experimental group and a control group (5 cases per group); 10 patients with Colorectal Cancer Liver Metastases will also be divided into the experimental group and the control group (5 cases per group). The purpose is to validate the safety and efficacy of multi-mode tumor ablation for liver malignant tumors, aiming to establish a multi-mode tumor treatment system and obtain multi-dimensional biomedical information from patients before, during and after ablation. The study will employ an interdisciplinary approach, integrating statistics, machine learning and artificial intelligence, to establish a new technical system for rapid efficacy evaluation. Additionally, it will establish a multi-omics artificial intelligence-assisted diagnostic and evaluation system based on radiomics. The system will use artificial intelligence algorithms to automatically locate and identify lesions based on imaging guidance information and accurately predict individual prognoses and anti-tumor immune states through comprehensive preoperative, intraoperative, and postoperative evaluations, providing an important basis for treatment planning, intraoperative dose adjustment, and subsequent treatment strategies.

Conditions

• Primary Liver Cancer
• Colorectal Cancer Liver Metastases

Interventions

Type	Name	Description
DEVICE	Multi-mode tumor treatment system	The intervention for this arm involves the use of a novel multi-mode tumor treatment system, developed by Shanghai MAaGI Medical Technology Co., Ltd. The system combines cryoablation and radiofrequency ablation in a single device. During the treatment, the tumor tissue is rapidly frozen to create an ice ball larger than the lesion by 5mm, followed by thawing and rewarming. Subsequently, the lesion is treated with radiofrequency ablation according to conventional procedures to ensure complete ablation within a safety margin of 5-10mm around the tumor.
DEVICE	Radiofrequency ablation therapeutic apparatus	The intervention for this arm involves the use of conventional radiofrequency ablation equipment, which is developed by MedSphere International (Shanghai) Co., Ltd.. During the treatment, the tumor is ablated using predefined power and time settings to ensure complete ablation within a safety margin of 5-10mm around the tumor.

Timeline

• Start date: 2022-10-12
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China