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

This study is currently recruiting participants.
Verified September 2011 by Dongfang Hospital
Sponsor:
Information provided by (Responsible Party):
Chen Weisheng, Dongfang Hospital
ClinicalTrials.gov Identifier:
NCT01429649
First received: September 3, 2011
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Lesions
 Procedure: cryotherapy or radiofrequency ablation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dongfang Hospital:

Primary Outcome Measures:
  • The changing of the lesion [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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:
  • The side effect of the therapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Intra and post-operative complications rates. Quality-of-life assessment


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429649

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
Investigators
Principal Investigator: Weisheng Chen, MD Dongfang Hospital
  More Information

No publications provided

Responsible Party: Chen Weisheng, The vice chief of the Thoracic Division, Dongfang Hospital
ClinicalTrials.gov Identifier: NCT01429649     History of Changes
Other Study ID Numbers: kj2011001
Study First Received: September 3, 2011
Last Updated: September 6, 2011
Health Authority: China: Ministry of Health

Keywords provided by Dongfang Hospital:
pure pulmonary ground glass opacity

ClinicalTrials.gov processed this record on May 19, 2013