Evaluating ablation therapy for lung cancer with ground-glass nodules
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
PHASE2 · Shanghai Zhongshan Hospital · NCT04905056
This study is testing if a special treatment called ablation therapy can help people with lung cancer that shows up as ground-glass nodules when they can't have regular surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04905056 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, two-center, single-arm Phase II study aimed at assessing the safety and effectiveness of ablation therapy for patients with lung cancer presenting as ground-glass nodules. Participants will be individuals aged 18 to 85 years who have been diagnosed with ground-glass opacities (GGOs) that have not improved after three months. The study will focus on patients who are unable to undergo traditional surgical procedures due to various reasons, including the presence of multiple nodules or previous surgeries. The primary goal is to determine how well ablation therapy can manage these specific lung cancer cases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with diagnosed GGOs that have shown progression and are not suitable for surgical intervention.
Not a fit: Patients with severe comorbid conditions, cognitive impairments, or those who have recently participated in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing lung cancer in patients with ground-glass nodules.
How similar studies have performed: While there is limited information on similar studies, the approach of using ablation therapy for lung cancer is gaining interest, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Thoracic Surgery, Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Qun Wang, Phd
- Email: 13301050210@fudan.edu.cn
- Phone: 86-21-64041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Progression