Lung Neoplasm Clinical Trial
Official title:
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Verified date | April 2024 |
Source | phenoMapper, LLC |
Contact | Henky Wibowo, MSc |
Phone | 4085203500 |
henky[@]flexperc.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 77 Years |
Eligibility | Inclusion Criteria: - Age 45-77 years at screening. - Confirmed NSCLC or solitary metastatic (oligometastatic) or pulmonary metastases from an extra thoracic primary tumor lung nodule through diagnostic biopsy - Must be eligible for curative lung resection (lobectomy). - For primary tumor, pre-ablated parenchymal tumor/lesion size = 20 mm if NSCLC, or = 10 mm for metastatic disease in diameter as measured from pre-operative CT image. - Willing to participate in all aspects of study protocol for duration of study. - Able to understand study requirements. - Signs informed consent form. - Boundary of tumor is at least 15 mm away from the pleura wall and/or fissure. Exclusion Criteria: - Any contraindication to bronchoscopy, for example: - Untreatable life-threatening arrhythmias. - Inability to adequately oxygenate the patient during the procedure. - Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated). - Recent myocardial infarction. - Uncorrectable coagulopathy. - Known coagulopathy. - Platelet dysfunction or platelet count < 100 x 109 cells/L OR taking anticoagulant or antiplatelet agents that cannot be safely ceased in the opinion of the pulmonologist or surgeon. - History of major bleeding with bronchoscopy. - Suspected pulmonary hypertension. - Moderate-to-severe pulmonary fibrosis. - Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD) within 3cm of tumor/lesion boundary: prior COPD assessment data is evaluated and PI consent is required. - Bullae >5 centimeter (cm) located in vicinity of target tumor/lesion. - Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic MWA, for example: - American Society of Anesthesiologists (ASA) physical status classification >P3 - Stage 3 heart failure - Severe cachexia - Severe respiratory insufficiency or hypoxia - Ongoing systemic infection. - Contraindication to general anesthesia. - Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure. - Participation in any other study in last 30 days. - Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study. - Life expectancy of less than 6 months. - Prior radiation therapy treatment in the target lobe. - Implantable pacemaker or defibrillator. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Melbourne Hospital | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
phenoMapper, LLC | NIH/NCI - Grant award number: R01CA218357 |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety - AE occurrence | Incidence of complications and occurrence of Adverse Events (AEs) | up to 7 days post ablation | |
Primary | Safety - AE frequency | Frequency of AEs | up to 7 days post ablation | |
Primary | Safety - ablated tissue assessment | Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation | up to 7 days post ablation | |
Primary | Technical Feasibility | Evidence of thermal ablation in portion of the tumor as assessed on histopathology | up to 7 days post ablation | |
Secondary | Navigational Success | Measured distance of phenoWave device tip relative to the planned position from CT data | Immediately after completion of procedure (day 0) | |
Secondary | Procedural Measures | Total procedure time and navigation time to position the device | Immediately after completion of procedure and navigation to the target (day 0) |
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