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Efficacy and safety of magnetic navigation assisted microwave ablation of pulmonary nodules

Efficacy and safety of magnetic navigation assisted microwave ablation of pulmonary nodules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061187
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early stage lung cancer

Interventions

Artificial intelligence assisted microwave ablation group :Artificial intelligence assisted microwave ablation

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age and gender: 18-85 years old (including 18 and 85 years old), regardless of gender; 2. Meet indications: (1) Patients with early non-small cell lung cancer (maximum tumor diameter <= 3 cm, no lymph node metastasis and distant metastasis), poor cardiopulmonary function, old age or refusing surgery. (2) Patients with pulmonary nodules highly suspected of early lung cancer include pure ground glass nodules, mixed ground glass nodules and solid nodules. (3) Patients with multiple primary lung cancer (MPLC) had residual pulmonary nodules after resection of the main focus; 3. According to note 1 of ECoG scoring standard, the physical condition level is 0-2; 4. Indexes of liver and kidney function: serum bilirubin is less than twice the upper limit of the normal range, ALT or AST is less than three times the upper limit of the normal range, and serum creatinine is less than twice the upper limit of the normal range. The above abnormalities can be excluded if they are considered to be caused by tumor infiltration. The left ventricular ejection function (LVEF) is 45% or greater; 5. Accept percutaneous microwave ablation assisted by artificial intelligence; 6. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Systemic tumor metastasis; 2. There are related contraindications: the absolute contraindications are severe bleeding tendency and platelet count < 50 × 10^9 / L and uncorrectable coagulation dysfunction; Anticoagulant therapy and / or antiplatelet drugs were discontinued for no more than 5-7 days before ablation. The relative contraindication is extensive extrapulmonary metastasis, and the expected survival is less than 3 months. There are serious complications and low immune function. 3. Active hepatitis B virus (HBV, Hepatitis B Virus), hepatitis C virus (HCV, Hepatitis C Virus) and HIV (HIV, Human Immunodeficiency Immunodeficiency) infection; 4. Active infection without adequate control: systemic fungal, bacterial, viral or other infections; 5. Patients with uncontrolled mental illness; 6. Combined with other life-threatening severe organ failure; 7. Major surgery for non diagnostic purposes within four weeks; 8. Other clinical studies within four weeks (observational studies are not included); 9. Pregnant or lactating women; 10. Other situations that the researcher believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
operation success rate;adverse events;

Countries

China

Contacts

Public ContactFenglei Yu

The Second Xiangya Hospital of Central South University

yufenglei@csu.edu.cn+86 13755182999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026