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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Lesions
• Intervention / Treatment: Procedure: cryotherapy or radiofrequency ablation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Recruiting
      • Dongfang Hospital
      • Contact: Yonggang Liang; Phone Number: 59388 +8659122859888; Email: war_ren@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Weisheng Chen, MD, Dongfang Hospital Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 3, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: pure pulmonary ground glass opacity
• Other Study ID Numbers: kj2011001