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

NCT06588569 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Primary Liver Cancer
  • Colorectal Cancer Liver Metastases

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Director of Interventional Therapy Department · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06588569 on ClinicalTrials.gov