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

NCT01429649 | Unknown Phase 3 DMC

• 1 other identifier: kj2011001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Lesions

Keywords

pure pulmonary ground glass opacity

Outcome Measures

Primary Outcomes (1)

• The changing of the lesion

  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.

  3 years

Secondary Outcomes (1)

• The side effect of the therapy.

  3 years

Study Arms (2)

ablation

EXPERIMENTAL

Cryoablation or Radiofrequency ablation for the pGGO

Procedure: cryotherapy or radiofrequency ablation

Follow up CT scann

NO INTERVENTION

The patients will receive follow up with CT scan every 6-9 months.

Interventions

cryotherapy or radiofrequency ablation PROCEDURE

Cryoablation or Radiofrequency ablation is performed under CT image guidance.

ablation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dongfang Hospital Beijing University of Chinese Medicine: lead

Study Sites (1)

Dongfang Hospital

Fuzhou, Fujian, 350025, China

RECRUITING

MeSH Terms

Interventions

Cryotherapy; Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Therapeutics; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Weisheng Chen, MD

  Dongfang Hospital Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weisheng Chen, MD

CONTACT

+8618960826090; weishengmd@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The vice chief of the Thoracic Division

Study Record Dates

• First Submitted: September 3, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

CN (1)