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Evaluation of Efficacy of Minimally Invasive Local Therapy for Lung Tumors and Its Impact on Breathing Function
Sponsor: Aurimas Macionis
Summary
This clinical study is evaluating different treatment options for patients with malignant lung tumors, including both primary lung cancer and tumors that have spread to the lungs from other parts of the body. The goal is to compare the safety, effectiveness, and quality-of-life impact of three approaches: surgery, stereotactic body radiotherapy (SBRT), and minimally invasive thermal ablation (microwave or cryoablation). Thermal ablation is a procedure in which a small antenna is inserted through the skin into the tumor and the cancer cells are destroyed using heat or freezing. SBRT uses precisely targeted radiation to destroy tumors, while surgery involves removing part of the lung. These methods are already used in routine care, but this study directly compares them to understand which patients may benefit most from each approach. In addition to cancer control, the study is measuring how these treatments affect breathing function. Patients will have regular follow-up visits with CT scans, breathing tests, and blood draws for up to two years. About 100 adults in Lithuania are expected to participate. The results will help doctors make better treatment recommendations, balancing cancer control with patient well-being, lung function, and quality of life.
Official title: Investigation of the Efficacy of Local Minimally Invasive Ablative Therapy for Pulmonary Tumors and Its Impact on Respiratory Function
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2022-11-22
Completion Date
2026-06-14
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
Surgery
Surgical resection performed under general anaesthesia, including lobectomy, segmentectomy, or atypical resection. All anatomical resections were accompanied by lymph node dissection, while atypical resections were performed without lymph node removal. Procedures were carried out via open thoracotomy, with some performed through mini-thoracotomy.
Ablation
Image-guided thermal ablation performed under general anaesthesia with CT guidance, including microwave ablation (TATO2 system, single or overlapping insertions) and cryoablation (CryoCare Touch™ system, three freeze-thaw cycles). Tract sealing was performed to minimize complications.
SBRT
Stereotactic body radiation therapy delivered with a Varian TrueBeam™ linear accelerator, using 4D-CT planning, daily cone-beam CT image guidance, RTOG-based organ-at-risk constraints, and individualized fractionation regimens with the aim of a median biologically effective dose of 100 Gy.
Locations (1)
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania