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
Recruiting · NCT04905056 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Ablation therapy
What this trial is about
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
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Department of Thoracic Surgery, Zhongshan Hospital, Fudan University - Shanghai, Shanghai Municipality, China