Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol.
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.
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.
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.
This trial is registered at ClinicalTrials.gov (Identifier: NCT05281237 ). This study was prospectively registered on March 15, 2022.
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.
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.
This trial is registered at ClinicalTrials.gov (Identifier: NCT05281237 ). This study was prospectively registered on March 15, 2022.
Authors
Beattie Beattie, Parrish Parrish, Ayasa Ayasa, Aranguren Aranguren, Uribe-Buritica Uribe-Buritica, Lopez Lopez, Pineda Pineda, Cheng Cheng, Senitko Senitko, Abdelghani Abdelghani, Magge Magge, Avendano Avendano, Kheir Kheir, Swenson Swenson, Parikh Parikh, Wilson Wilson, VanderLaan VanderLaan, Gangadharan Gangadharan, Majid Majid
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