Clinical trial NCT05281237: Avecure Flexible Microwave Ablation Probe For Lung Nodules
Official title: Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage I - II Primary Lung Cancer
Stage I Lung Cancer
Stage II Lung Cancer
Lung Cancer Stage I
Lung Cancer Stage II
Lung Cancer
Keywords: Stage I - II primary lung cancer
Stage I Lung Cancer
Stage II Lung Cancer
Lung Cancer Stage I
Lung Cancer Stage II
Lung Cancer
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: MedWaves, Inc
name: Dana-Farber Cancer Institute
First posted: 2022-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of Planned Ablations.
timeFrame: Day 1
measure: Pathological changes in the tumor tissue.
timeFrame: 4 weeks
Secondary outcomes:
measure: Histological changes in lung tissue outside the zone of predicted ablation.
timeFrame: 4 weeks
measure: Immune-histochemical changes in the tumor tissue.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jason Beattie, MD
role: PRINCIPAL_INVESTIGATOR
References: