Using microwave energy to treat lung tumors
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
This study is testing whether a new microwave treatment can safely destroy lung tumors in patients who are eligible for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 45 Years to 77 Years |
| Sex | All |
| Sponsor | phenoMapper, LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06158971 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and technical feasibility of the phenoWave Microwave Ablation System for ablating lung lesions. It is a prospective, single-arm, single-center study that aims to determine how effectively microwave energy can be used to target and destroy tumors in the lung. Participants will undergo flexible bronchoscopic microwave ablation as part of the intervention. The study focuses on patients with confirmed lung neoplasms who are eligible for curative lung resection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45-77 with confirmed non-small cell lung cancer or solitary metastatic lung nodules who are eligible for curative lung resection.
Not a fit: Patients with contraindications to bronchoscopy or those with severe respiratory or cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive treatment option for patients with lung tumors, potentially improving outcomes and reducing recovery times.
How similar studies have performed: Other studies have shown promising results with microwave ablation techniques in treating lung tumors, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne, Victoria
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Daniel Steinfort, MBBS, BMedSci, FRACP, PhD — Melbourne Health
- Study coordinator: Henky Wibowo, MSc
- Email: henky@flexperc.com
- Phone: 4085203500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.