The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors
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|ClinicalTrials.gov Identifier: NCT04044326|
Recruitment Status : Withdrawn (Machine cannot provide)
First Posted : August 5, 2019
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Procedure: The Solero Microwave Ablation||Not Applicable|
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor location. The tumors located adjacent to big vessels such as inferior vena cava (IVC), could not be ablated completely sometimes.
Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels. Several pre-clinical studies have already demonstrated MWA is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE mark and FDA approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 20 inoperable patients with liver cancers adjacent to IVC in our hospital. The researchers will evaluate the potential side effect and ablate effect of tumors by abdominal CT or MRI, and the researchers will also follow-up this patients for 4 months to evaluate the complete ablation rate and local recurrence rate. We will appraisal the clinical feasibility and advantage of the system by this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||microwave ablation|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Inferior Vena Cava|
|Actual Study Start Date :||September 1, 2019|
|Actual Primary Completion Date :||January 6, 2020|
|Actual Study Completion Date :||January 22, 2020|
Experimental: microwave ablation (MWA)
20 patients with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated with microwave ablation (MWA)
Procedure: The Solero Microwave Ablation
The Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA
- the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria [ Time Frame: up to one year ]The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.
- safety and local tumor recurrences [ Time Frame: within 30 days of treatment ]The safety endpoint will be treatment-related Serious Adverse Events occurring within 30 days of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044326
|National Taiwan University Hospital|
|Taipei, Test2, Taiwan, 100|
|Principal Investigator:||Kai-Wen Huang, MDPHD||NTUH|