Microwave Ablation in Pulmonary Malignancies

Study Overview
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Brief Summary
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Lung cancer remains to be an important global issue as it is the leading cause of cancer_ related mortality for both men and women worldwide .Since more than two thirds of cases are diagnosed at an advanced stage,the survival rate of lung cancer is one of the lowest among all cancers.

Detailed Description
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Currently , Surgery is one of the curative treatment option for primary lung cancer but most patients are either diagnosed at an advanced stage or are unfit for surgery due to medical co_morbidities or poor underlying lung reserve , less than a third of all lung cancer patients can undergo surgical resection . Lung metastasectomy is considered a therapeutic option increasing the survival rate for patients of pulmonary metastases but only 25%_30% of patients benefits from lung metastasectomy due to multiplicity of pulmonary nodules or medical co_ morbidities . In spite of a significant improvement of lung cancer chemotherapy and radiotherapy in recent years , the overall clinical outcome is less than satisfactory compared with that brought by surgical resection .Thus , it is urgent to provide a method which is more effective than chemotherapy and radiotherapy and nearly effective as the surgical treatment for the patients who are not eligible for surgery. Local thermal ablation therapy of the tumor is the focus of recent research in the past decades .This method is to deliver specific energy into the tumor tissue under the guidance of image technology , which make the local tissue quickly reach 60°C where an irreversible coagulative necrosis happens leading to necrosis of tumor cells . CT_guided Microwave ablation is a minimally invasive technique that may be an alternative treatment option for management of lung cancer in patients who are not candidate for surgery .This method not only kill the insitu lung cancer cells , but also protect lung cancer tissue .It can produce large volumes of cellular necrosis with reduced procedure time , can use multiple antennae and can be used in lesions with cystic component and/or in proximity to vascular structures. Thus, CT guided microwave ablation is a promising new technique that is convenient ,easy ,causing less trauma ,associated with no need for general anaesthesia , fast recovery and less complications.

Official Title
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CT_ Guided Percutaneous Microwave Ablation in Treatment of Pulmonary Malignancies

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient has good compliance and sign the informed consent. patient with lung cancer who lost the opportunity of surgical resection. patient has one or more metastatic lung nodules (not more than 5) Exclusion Criteria: patient is pregnant or breast feeding . patient with uncorrectable coagulopathy. There are large blood vessels or important structures adjacent to lung lesion. patient with more than five nodules
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT_ guided percutaneous microwave ablation<br>The procedure will be done under anaesthesia by interventional radiologist | Procedure: Microwave ablation<br>* CT_guided Microwave ablation is a minimally invasive technique that kill the insitu lung cancer cells, produce large volumes of cellular necrosis with reduced procedure time .According to the preoperative CT image of the patient , we will determine the focal position of the lesion ,it's size and it's relationship with adjacent organs to choose the optimal puncture point , puncture path and proper microwave antenna and to set the power and time of ablation.Then under the guidance of CT , the tip of antenna will be sent into the focus by puncture with ablation power of 60_80 W .according to tumor size , the ablation time will be determined.Needle track coagulation will be done to prevent seeding of malignant cells. After ablation a CT scan will be done immediately to observe the size ,shape and relation to nearby organ of the lesion and to determine if there is pneumothorax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving adequacy of ablation | Defined as perilesional circumferential solid area of ground glass opacification of >4mm | 24 hours post ablation | 
| Percentage of patients achieving technical efficacy | Defined as lack of enhancement within the ablated zone | 1 month after ablation | 
| Local progression free survival | The interval between microwave ablation and evidence of local recurrence. Local recurrence defined as enlargement of the zone , the development of contrast enhancement in the part of the zone or change in the size of the ablated zone as a result if enlargement of one area. | From the date of ablation up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Defined as incidence of intra , peri and post procedural complications | From the date of ablation up to six months follow up |