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

Pulmonary Lesions Clinical Trial

— pGGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01429649
• Other study ID #: kj2011001
• Status: Recruiting
• Phase: Phase 3
• First received: September 3, 2011
• Last updated: September 6, 2011
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2011
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Weisheng Chen, MD
• Phone: +8618960826090
• Email: weishengmd[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Lesions

Intervention

Procedure:
• cryotherapy or radiofrequency ablation
Cryoablation or Radiofrequency ablation is performed under CT image guidance.

Locations

Country	Name	City	State
China	Dongfang Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The side effect of the therapy.	Intra and post-operative complications rates. Quality-of-life assessment	3 years	No