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

September 3, 2011
September 6, 2011
September 2011
October 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01429649 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Lesions
Procedure: cryotherapy or radiofrequency ablation
Cryoablation or Radiofrequency ablation is performed under CT image guidance.
  • Experimental: ablation
    Cryoablation or Radiofrequency ablation for the pGGO
    Intervention: Procedure: cryotherapy or radiofrequency ablation
  • No Intervention: Follow up CT scann
    The patients will receive follow up with CT scan every 6-9 months.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Weisheng Chen, MD +8618960826090 weishengmd@hotmail.com
China
 
NCT01429649
kj2011001
Yes
Chen Weisheng, Dongfang Hospital
Dongfang Hospital
Not Provided
Principal Investigator: Weisheng Chen, MD Dongfang Hospital
Dongfang Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP