Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC

Ki nem vehet részt

• Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation
• Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging
• Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy
• Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study; Surgical Resection Group Inclusion Criteria
• Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection
• Tumour size between 2.5 and 3.0 cm, or smaller lesions for which surgery is considered the more appropriate option based on tumour features or safety concerns
• Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins
• Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging
• Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment
• High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred
• Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study
• Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4
• Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection
• Adults aged ≥18 years
• Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
• Centrally located tumours within the inner third of the lung or those requiring ablation near major airways
• Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved
• Pregnant or breastfeeding women
• Inability or unwillingness to comply with study procedures
• Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
• Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging
• Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
• Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins)
• Pregnant or breastfeeding women
• Inability or unwillingness to comply with study procedures

Egyéb feltételek

• Bronchoscopic Microwave Ablation Group Inclusion Criteria
• Adults aged ≥18 years
• Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
• Determined by multidisciplinary evaluation to be an appropriate candidate for bronchoscopic ablation as part of standard clinical care, and the patient agrees to a lung-preserving treatment approach
• Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT
• Tumour located in the middle or peripheral third of the lung parenchyma
• Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required
• Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols
• Pulmonary function results or clinical assessment indicate significant benefit from preserving lung tissue, such as predicted FEV1 or DLCO less than 40%, or clinician judgment that lung preservation is critical for quality of life
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2