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

NCT ID: NCT01429649

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Pulmonary Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ablation

Cryoablation or Radiofrequency ablation for the pGGO

Group Type: EXPERIMENTAL

cryotherapy or radiofrequency ablation

Intervention Type: PROCEDURE

Cryoablation or Radiofrequency ablation is performed under CT image guidance.

Follow up CT scann

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cryotherapy or radiofrequency ablation

Cryoablation or Radiofrequency ablation is performed under CT image guidance.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chen Weisheng

The vice chief of the Thoracic Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weisheng Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Dongfang Hospital Beijing University of Chinese Medicine

Locations

Dongfang Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weisheng Chen, MD

Role: CONTACT

weishengmd@hotmail.com

+8618960826090

Facility Contacts

Yonggang Liang

Role: primary

war_ren@163.com

+8659122859888 ext. 59388

Other Identifiers

kj2011001

Identifier Type: -

Identifier Source: org_study_id