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

Phase 3

• Conditions: Pulmonary Lesions
• Interventions: Procedure: cryotherapy or radiofrequency ablation

• Registration Number: NCT01429649
• Lead Sponsor: Dongfang Hospital Beijing University of Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-03
• Study First Submitted QC: 2011-09-06
• Last Update Submitted: 2011-09-06
• Study First Posted: 2011-09-07
• Last Update Posted: 2011-09-07
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ablation	cryotherapy or radiofrequency ablation	Cryoablation or Radiofrequency ablation for the pGGO

Primary Outcome Measures

Name	Time	Method
The changing of the lesion	3 years	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.

Secondary Outcome Measures

Name	Time	Method
The side effect of the therapy.	3 years	Intra and post-operative complications rates. Quality-of-life assessment

Trial Locations

Locations (1)

Dongfang Hospital; 🇨🇳 Fuzhou, Fujian, China