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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · May 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called ablation therapy for patients with lung cancer that appears as ground-glass nodules (GGNs) on lung scans. Ground-glass nodules are spots on the lung that may indicate early-stage cancer, and this trial aims to see if the ablation therapy is safe and effective for these patients. The study is currently recruiting participants aged between 18 and 85 who have GGNs that have not improved after three months and meet specific size requirements.

To be eligible, patients should have a single ground-glass nodule that has shown clear signs of growth or certain characteristics that suggest it may be more concerning. Participants should also be unable to undergo traditional surgery for various reasons. Those interested in joining the study can expect to receive the ablation therapy, and they will be carefully monitored for safety and effectiveness. However, patients who have participated in other clinical trials recently, have severe health issues, or certain allergies may not qualify. It’s important for potential participants to discuss this opportunity with their healthcare team to see if this study is right for them.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 85 years;
• • 2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
• • 3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
• • 4. 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
• • 5. 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
• • 6. The patient is able to understand and comply with the study and has provided written informed consent
• Exclusion Criteria:
• • 1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial
• • 2. had severe disease conditions
• • 3. allergy to narcotic drugs
• • 4. had other autoimmune disease
• • 5. dementia or cognitive impairment can't cooperate with researchers
• • 6. any local treatment other than ablation was received within 4 weeks before the study