Avecure Flexible Microwave Ablation Probe For Lung Nodules

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281237
• Other study ID #: 21-412
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Jason Beattie, MD
• Phone: (617) 632- 8252
• Email: jbeattie[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Cancer Stage I
• Lung Cancer Stage II
• Lung Neoplasms
• Stage I Lung Cancer
• Stage II Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, MedWaves, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Planned Ablations.	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.	Day 1
Primary	Pathological changes in the tumor tissue.	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.	4 weeks
Secondary	Histological changes in lung tissue outside the zone of predicted ablation.	A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.	4 weeks
Secondary	Immune-histochemical changes in the tumor tissue.	Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.	4 weeks