Microwave ablation for treating lung cancer nodules
Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
This study is testing a new microwave treatment for destroying small lung cancer nodules to see if it is safe and effective for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05281237 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 22 and older with Stage I - II primary lung cancer and solitary nodules up to 3 cm.
Not a fit: Patients with contraindications for flexible bronchoscopy or those with target nodules smaller than 1.0 cm 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 early-stage lung cancer.
How similar studies have performed: While this specific approach is novel, similar microwave ablation techniques have shown promise in treating other types of tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
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.