Malignant lung nodule
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Ages = 18 years, any gender 2: Subjects planning to undergo ablation treatment for malignant or suspected malignant lung nodules, including stage IA primary peripheral non-small cell lung cancer, solitary lung metastasis, or lung nodules with malignant potential 3: Subjects with no more than 3 nodules on one side of the lungs (= 5 nodules on both sides), with the nodules to be ablated having a diameter between 10mm and 30mm 4: Subjects who refuse or are deemed unsuitable for surgical resection or stereotactic radiation therapy 5: Subjects or their legal guardians who can comprehend the study's objectives, demonstrate sufficient compliance with the study protocol, and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1: Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of =3 2: Subjects who have received chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive treatments for tumors or lung nodules within 30 days prior to ablation 3: Subjects with severe pulmonary fibrosis and pulmonary hypertension 4: Subjects with poorly controlled pleural effusion 5: Subjects with impaired consciousness or inability to cooperate with treatment 6: Subjects with a significant bleeding tendency and notable abnormalities in blood parameters that cannot be corrected within a short period (platelet count 18s, prothrombin activity 38.5?), etc.) 14: Subjects with an expected survival of less than 6 months 15: Subjects with implanted cardiac pacemakers 16: Pregnant or lactating women 17: Subjects who have participated in other clinical trials within 3 months preceding the start of this research treatment 18: Subjects deemed unsuitable for participation in this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ablation rate of pulmonary nodules; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate ablation achievement rate;Complete ablation rate of multiple pulmonary nodules;Evaluation of Ablator Operational Performance;Ablation Needle Operational Performance Assessment; | — |
Countries
China
Contacts
Public ContactYe Xin
Shandong Qianfoshan Hospital
Outcome results
None listed