Avecure Flexible Microwave Ablation Probe For Lung Nodules

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Lung Cancer Stage I; Lung Cancer Stage II; Stage I Lung Cancer; Stage I - II Primary Lung Cancer; Stage II Lung Cancer
• Intervention / Treatment: Device: AveCure 16 Gauge Flexible Microwave Ablation Probe

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adnan Majid, MD; Phone Number: (617) 632- 8252; Email: amajid@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Adnan Majid, MD
      • Sub-Investigator: Mihir S Parikh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: MedWaves, Inc
• Investigators: Principal Investigator: Adnan Majid, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Lung Cancer; Stage I - II primary lung cancer; Stage I Lung Cancer; Stage II Lung Cancer; Lung Cancer Stage I; Lung Cancer Stage II
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21-412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes