Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Rate of Planned Ablations.
Study Overview
Brief Summary
This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.
This research study involves microwave ablation (MWA)
Detailed Description
This will be a single arm, prospective cohort study.
The names of the study intervention involved in this study is:
- Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
- A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Participants will receive the study intervention and will be followed for 30 days.
- It is expected that about 10 people will take part in this research study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Rate of Planned Ablations.
Time Frame: Day 1
Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.
Pathological changes in the tumor tissue.
Time Frame: 4 weeks
Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.
Secondary Outcomes
- Histological changes in lung tissue outside the zone of predicted ablation.(4 weeks)
- Immune-histochemical changes in the tumor tissue.(4 weeks)
Investigators
Jason A Beattie
Principal Investigator
Beth Israel Deaconess Medical Center