Journal Article

Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol

Beattie, Jason, Cheng, George, Lopez, Mariana Nino, Majid, Adnan, Wilson, Jennifer, Senitko, Michal, Pineda, Cristiana M., Swenson, Kai, Gangadharan, Sidhu, Abdelghani, Ramsy, Kheir, Fayez, Parikh, Mihir, Avendano, Camilo A., Magge, Anil, Uribe-Buritica, Francisco L., Parrish, Ray, Ayasa, Laith, Aranguren, Paula, VanderLaan, Paul A.

2025

Overview

Background Microwave ablation is a well-established therapeutic option for percutaneous treatment of lung tumors, however transbronchial microwave ablation remains under investigation. Our study aims to evaluate the safety and feasibility of transbronchial microwave ablation for lung cancer using state of the art bronchoscopy and imaging platforms and a microwave ablation system featuring tumor permittivity feedback control. Methods This study is an investigator initiated multicenter prospective diagnose-stage-treat, then resect, trial designed to evaluate the safety and feasibility of bronchoscopic microwave ablation. Patients with surgically resectable, treatment-naïve primary lung cancer tumors ≤ 3.0 cm will undergo shape sensing robotic assisted bronchoscopy (ssRAB) with cone-beam CT imaging for diagnostic sampling. Following intraoperative pathologic verification of malignancy, transbronchial microwave ablation will be performed. Cone-beam CT imaging will be used for verification of microwave probe position and for evaluation of ablation zone. Dedicated CT chest will be performed two weeks post-ablation. Two to four weeks following ablation patients will undergo standard of care surgical resection. Post-resection histopathologic analysis will evaluate treatment effect. Enrollment began March 2024 as a single-center study. The study will transition to multi-center to increase recruitment and improve generalizability. Discussion This study will be a first of its kind using shape sensing robotic assisted bronchoscopy and cone-beam CT for transbronchial microwave ablation. Our treat and resect design will provide short-term clinical safety data and vital treatment effect data. Trial registration This trial is registered at ClinicalTrials.gov (Identifier: NCT05281237 ). This study was prospectively registered on March 15, 2022.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Ablation / Ablation (Surgery) / Ablation Techniques - methods / Antibiotics / Bronchoscopy / Bronchoscopy - methods / Cancer / Care and treatment / Clinical Trials as Topic / Computed tomography / Cone-Beam Computed Tomography / CT imaging / Enrollments / Feasibility / Feasibility Studies / Feedback control / Female / Health aspects / Humans / Internal Medicine / Lung cancer / Lung diseases / Lung Neoplasms - diagnostic imaging / Lung Neoplasms - surgery / Male / Malignancy / Medical equipment / Medical imaging / Medicine / Medicine & Public Health / Microwave ablation / Microwave probes / Microwaves - therapeutic use / Middle Aged / Mortality / Multicenter Studies as Topic / Oncology, Experimental / Patients / Percutaneous treatment / Physiological apparatus / Pilot projects / Prospective Studies / Respiratory agents / Robotic Surgical Procedures / Robotics / Safety / Standard of care / Study Protocol / Surgery / Thoracic surgery / Transbronchial lung ablation / Tumors / Verification