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ACTIVE NOT RECRUITING
NCT06588569
NA

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-10-12

Completion Date

2025-12

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China