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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01429649
Recruitment Status : Unknown
Verified September 2011 by Chen Weisheng, Dongfang Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Information provided by (Responsible Party):
Chen Weisheng, Dongfang Hospital

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 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

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MedlinePlus related topics: Eye Wear
U.S. FDA Resources

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.

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01429649

Contact: Weisheng Chen, MD +8618960826090

China, Fujian
Dongfang Hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Yonggang Liang    +8659122859888 ext 59388   
Sponsors and Collaborators
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Principal Investigator: Weisheng Chen, MD Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Responsible Party: Chen Weisheng, The vice chief of the Thoracic Division, Dongfang Hospital Identifier: NCT01429649     History of Changes
Other Study ID Numbers: kj2011001
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Chen Weisheng, Dongfang Hospital:
pure pulmonary ground glass opacity