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

Dongfang Hospital Beijing University of Chinese Medicine

Status and phase: Unknown; Phase 3

Conditions: Pulmonary Lesions

Treatments: Procedure: cryotherapy or radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01429649

kj2011001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ablation

Experimental group

Description:

Cryoablation or Radiofrequency ablation for the pGGO

Treatment:

Procedure: cryotherapy or radiofrequency ablation

Follow up CT scann

No Intervention group

Description:

The patients will receive follow up with CT scan every 6-9 months.