Microwave ablation for treating lung cancer nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of the AveCure Flexible Microwave Ablation Probe in destroying cancerous lung nodules up to 3 cm in size. The study employs a single-arm, prospective cohort design, utilizing Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy for the microwave ablation procedure. Participants will undergo a rapid on-site evaluation to confirm malignancy before the ablation, followed by a 30-day follow-up period. The study aims to assess the safety and efficacy of this novel bronchoscopic approach for treating solitary pulmonary nodules.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)
* Participants must be at least 22 years old and able to provide consent

Exclusion Criteria:

* 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
* Pacemaker, implantable cardioverter, or another electronic implantable device
* Patient cannot tolerate bronchoscopy
* Patients with coagulopathy
* Patients in other therapeutic lung cancer studies
* Subject is pregnant or breastfeeding
* COVID-19 positive patient at the time of procedure.

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jason Beattie, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Jason Beattie, MD
• Email: jbeattie@bidmc.harvard.edu
• Phone: (617) 632- 8252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.