This clinical trial evaluates the feasibility of the AveCure flexible microwave ablation probe for treating patients with malignant central airway obstruction. Malignant central airway obstruction (CAO) results from a cancerous tumor in-growth into the airways. Relief of CAO has been shown to improve respiratory symptoms and quality of life. The AveCure flexible microwave destruction of tissue (ablation) probe is a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic). The AveCure probe is introduced into the airway and placed in contact with the obstruction to apply energy. The amount of energy will be determined based on the lesion size. Treatment with the energy will be performed until the airway obstruction has been relieved or deemed appropriate by the treating physician. This study may help researchers learn whether the AveCure flexible microwave ablation probe is a safe and effective intervention for bronchoscopic treatment of malignant central airway obstruction.
Additional locations may be listed on ClinicalTrials.gov for NCT06105606.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Feasibility of the AveCure microwave technology to ablate a target malignant central and lobar airway lesions causing > 50% obstruction, defined as at least 9/10 of the planned ablations (90%) successfully performed bronchoscopically according to the study protocol.
SECONDARY OBJECTIVES:
I. The number of required bronchoscopic re-interventions at 6 months to achieve airway patency.
II. Evaluation of peri-procedural, device-related adverse events attributed to the AveCure microwave technology device when used to ablate target malignant central or lobar airway lesions.
III. Percentage of airway obstruction assessed at bronchoscopy and on computed tomography (CT) scan after the study procedure measured through the Myer-Cotton grading system and percentage change in luminal cross sectional area.
IV. Changes in quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) and the Saint George Respiratory Questionnaire (SGRQ).
V. Changes in subjective perception of dyspnea as measured by the modified Medical Research Council dyspnea scale (mMRC).
VI. Number and type of additional tools that are used during bronchoscopy.
VII. Estimated blood loss during bronchoscopic treatment of the CAO, as well as Nashville bleeding grade 4.
VIII. Changes in peak flow measurements pre and post procedure as well as pulmonary function test (PFT) values after the procedure when available.
IX. Overall survival and mechanical ventilation-free survival at 6 months.
X. Histologic characteristics of tissue ablated with the AveCure microwave technology device.
XI. Microwave ablation (MWA) parameters including number of MW energy applications, time of application, total time of MWA, total energy delivered, and temperature during ablation.
OUTLINE:
Patients undergo standard of care (SOC) bronchoscopy and ablation using the AveCure microwave ablation probe and digital imaging of the central airway on study. Patients may undergo other therapeutic ablation modalities, as well as tissue sample biopsy at the time of study intervention per the discretion of the treating physician. Patients also undergo CT throughout the study.
After completion of study intervention, patients are followed up at 1, 3, 6, and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJason Beattie
