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

Tracking Information

First Received Date ^ICMJE

September 3, 2011

Last Updated Date

September 6, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01429649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Lesions

Intervention ^ICMJE

Procedure: cryotherapy or radiofrequency ablation

Cryoablation or Radiofrequency ablation is performed under CT image guidance.

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Weisheng Chen, MD

+8618960826090

weishengmd@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01429649

Other Study ID Numbers ^ICMJE

kj2011001

Has Data Monitoring Committee

Yes

Responsible Party

Chen Weisheng, Dongfang Hospital

Study Sponsor ^ICMJE

Dongfang Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Weisheng Chen, MD

Dongfang Hospital

Information Provided By

Dongfang Hospital

Verification Date

September 2011

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

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