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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2011 by Chen Weisheng, Dongfang Hospital.
Recruitment status was: Recruiting

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 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Chen Weisheng, Dongfang Hospital:

Primary Outcome Measures:

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:

The side effect of the therapy. [ Time Frame: 3 years ]
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Affiliated to Beijing University of Chinese Medicine

Investigators


Principal Investigator:	Weisheng Chen, MD	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

More Information


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

Keywords provided by Chen Weisheng, Dongfang Hospital:


pure pulmonary ground glass opacity

ClinicalTrials.gov processed this record on September 21, 2017

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