Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Launched by PHENOMAPPER, LLC · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called microwave ablation for patients with lung tumors. The goal is to see how safe this treatment is and whether it works well for targeting specific lesions in the lung. The trial is currently looking for participants aged between 45 and 77 who have been diagnosed with non-small cell lung cancer or certain types of metastatic lung tumors. To be eligible, participants need to be considered for a surgical procedure called lobectomy, which is a way to remove part of the lung.

If you or someone you know is interested in participating, you can expect to undergo a procedure where microwave energy is used to treat the tumor. Participants must be willing to follow the study guidelines and be able to provide informed consent. However, there are certain health conditions that may prevent someone from joining, such as serious heart or lung issues or being unable to stop specific blood-thinning medications before the procedure. Your doctor can help determine if this trial is a suitable option based on individual health circumstances.

Gender

ALL

Eligibility 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.