A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
Phase 3
20 Years
80 Years
20 Years
80 Years
Open (Enrolling)
Both
Pulmonary Lesions
Both
Pulmonary Lesions
Trial Information
A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The changing of the lesion
Outcome Description:
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.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Weisheng Chen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dongfang Hospital
Authority:
China: Ministry of Health
Study ID:
kj2011001
NCT ID:
NCT01429649
Start Date:
September 2011
Completion Date:
December 2014
Related Keywords:
- Pulmonary Lesions
- pure pulmonary ground glass opacity
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