This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.
This research study involves microwave ablation (MWA)
Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
Resection/surgical candidate (lobectomy or greater)
Subjects in whom flexible bronchoscopy is contraindicated
Target nodule < 1.0 cm
Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
Single group
AveCure 16 Gauge Flexible Microwave Ablation Probe
DeviceMicrowave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery
Rate of Planned Ablations.
Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.
Pathological changes in the tumor tissue.
Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.
Histological changes in lung tissue outside the zone of predicted ablation.
A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.
Immune-histochemical changes in the tumor tissue.
Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.
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Beth Israel Deaconess Medical Center
Lead sponsor
MedWaves, Inc
Collaborator
Dana-Farber Cancer Institute
Collaborator
