Avecure Flexible Microwave Ablation Probe For Lung Nodules

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05281237

Collaborator

MedWaves, Inc (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stage I - II Primary Lung Cancer Stage I Lung Cancer Stage II Lung Cancer Lung Cancer Stage I Lung Cancer Stage II Lung Cancer	Device: AveCure 16 Gauge Flexible Microwave Ablation Probe	N/A

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.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.	Device: AveCure 16 Gauge Flexible Microwave Ablation Probe Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery Other Names: Avecure

Arm

Intervention/Treatment

Experimental: AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

Device: AveCure 16 Gauge Flexible Microwave Ablation Probe

Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery

Other Names:

Avecure

Outcome Measures

Primary Outcome Measures

Rate of Planned Ablations. [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. [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 Outcome Measures

Histological changes in lung tissue outside the zone of predicted ablation. [4 weeks]
A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.
Immune-histochemical changes in the tumor tissue. [4 weeks]
Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.