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

• ClinicalTrials.gov Identifier: NCT01429649
• Recruitment Status: Unknown
• First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Information provided by (Responsible Party): Chen Weisheng, Dongfang Hospital Beijing University of Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Lesions	Procedure: cryotherapy or radiofrequency ablation	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
• Study Start Date: September 2011
• Estimated Primary Completion Date: October 2014
• Estimated Study Completion Date: December 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. The changing of the lesion [ Time Frame: 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 :

1. The side effect of the therapy. [ Time Frame: 3 years ]
   Intra and post-operative complications rates. Quality-of-life assessment

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Weisheng Chen, MD; +8618960826090; weishengmd@hotmail.com

Locations

China, Fujian

Dongfang Hospital; Recruiting

Fuzhou, Fujian, China, 350025

Contact: Yonggang Liang +8659122859888 ext 59388 war_ren@163.com

Sponsors and Collaborators

Dongfang Hospital Beijing University of Chinese Medicine

Investigators

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

More Information

• Responsible Party: Chen Weisheng, The vice chief of the Thoracic Division, Dongfang Hospital Beijing University of Chinese Medicine
• ClinicalTrials.gov Identifier: NCT01429649 History of Changes
• Other Study ID Numbers: kj2011001
• First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Last Verified: September 2011

Keywords provided by Chen Weisheng, Dongfang Hospital Beijing University of Chinese Medicine:

pure pulmonary ground glass opacity

Additional relevant MeSH terms:

Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors