Status:
RECRUITING
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Lead Sponsor:
phenoMapper, LLC
Collaborating Sponsors:
NIH/NCI - Grant award number: R01CA218357
Conditions:
Lung Neoplasm
Eligibility:
All Genders
45-77 years
Phase:
NA
Brief Summary
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
Detailed Description
This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of les...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06158971
Start Date
March 12 2024
End Date
January 31 2025
Last Update
April 4 2024
Active Locations (1)
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1
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050