Status:
RECRUITING
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Progression
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
Eligibility Criteria
Inclusion
- Aged between 18 and 85 years;
- GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
- The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
- For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
- The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
- The patient is able to understand and comply with the study and has provided written informed consent
Exclusion
- Patients who participated in any drug and / or medical device clinical trials within one month before the trial
- had severe disease conditions
- allergy to narcotic drugs
- had other autoimmune disease
- dementia or cognitive impairment can't cooperate with researchers
- any local treatment other than ablation was received within 4 weeks before the study
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04905056
Start Date
January 1 2021
End Date
December 31 2028
Last Update
May 27 2021
Active Locations (1)
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1
Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032