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Avecure Flexible Microwave Ablation Probe For Lung Nodules

Primary Purpose

Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AveCure 16 Gauge Flexible Microwave Ablation Probe
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I - II Primary Lung Cancer focused on measuring Stage I - II primary lung cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 16, 2022
Last Updated
March 11, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
MedWaves, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05281237
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
MedWaves, Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AveCure 16 Gauge Flexible Microwave Ablation Probe
Other Intervention Name(s)
Avecure
Intervention Description
Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery
Primary Outcome Measure Information:
Title
Rate of Planned Ablations.
Description
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.
Time Frame
Day 1
Title
Pathological changes in the tumor tissue.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Histological changes in lung tissue outside the zone of predicted ablation.
Description
A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.
Time Frame
4 weeks
Title
Immune-histochemical changes in the tumor tissue.
Description
Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adnan Majid, MD
Phone
(617) 632- 8252
Email
amajid@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Majid, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adnan Majid, MD
First Name & Middle Initial & Last Name & Degree
Mihir S Parikh, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Avecure Flexible Microwave Ablation Probe For Lung Nodules

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