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

NCT ID: NCT04905056

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2028-12-31

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

Conditions

Progression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ablation therapy

Intervention Type: OTHER

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

Interventions

Ablation therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xi Junjie

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qun Wang, Phd

Role: CONTACT

13301050210@fudan.edu.cn

86-21-64041990

Facility Contacts

Qun Wang, phd

Role: primary

13301050210@fudan.edu.cn

86-21-64041990

Other Identifiers

B2021-088R

Identifier Type: -

Identifier Source: org_study_id