RecruitingPhase 2NCT04905056

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

120 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

Interventions

OTHERAblation therapy

Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules


Locations(1)

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT04905056


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