Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO)

Study Overview
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Brief Summary
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With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years. The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.

Official Title
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A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity

Conditions
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Pulmonary Lesions

Intervention / Treatment
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* Procedure: cryotherapy or radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The lesion(s) treated with ablation must be =< 2.0 cm in greatest dimension All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation Platelet count ≥ 100 x 109/L International normalized ratio (INR) < 1.5 Absolute neutrophil count (ANC) ≥ 1.5 x 109/L A signed study specific consent form is required Exclusion Criteria: Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years Unable to lie flat or has respiratory distress at rest Uncontrolled coagulopathy or bleeding disorders Evidence of active systemic, pulmonary, or pericardial infection Women who are pregnant or breastfeeding Patients with poor pulmonary function

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ablation<br>Cryoablation or Radiofrequency ablation for the pGGO | Procedure: cryotherapy or radiofrequency ablation<br>* Cryoablation or Radiofrequency ablation is performed under CT image guidance.<br>|
| No Intervention: Follow up CT scann<br>The patients will receive follow up with CT scan every 6-9 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changing of the lesion | To determine the efficacy rate of CT image guided ablation for pulmonary focal pGGO. To determine the feasibility and safety of CT image guided ablation in patients with pulmonary pGGO. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The side effect of the therapy. | Intra and post-operative complications rates. Quality-of-life assessment | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pure pulmonary ground glass opacity