Image - Navigated Resection of Lung Nodules

Study Overview
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Brief Summary
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This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.

Official Title
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Image - Navigated Resection of Lung Nodules

Conditions
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Lung Diseases

Intervention / Treatment
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* Device: lung resection with Lung Resection Marker Locator Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers. Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator) Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only) Exclusion Criteria: Female subjects pregnant or breastfeeding Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator. Patients who are not scheduled for lung surgery -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VATS resection with J-bar<br>Each patient with a lung nodule meeting criteria will undergo a lung resection which could be one of three approaches: iVATS with Dyna-CT, VATS, or open. Each approach will use a the experimental device the Lung Resection Marker Locator Kit | Device: lung resection with Lung Resection Marker Locator Kit<br>* Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the measurements from the J-bar fiducial to the first staple line obtained by the device in vivo to that performed in the frozen section room on the lung specimen obtained (which includes both the J bar and the staple line). | device feasibility | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether coefficient is needed | To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists | 1 day | 
| time required for device placement | 3. To determine the length of time needed for the placement of the device and record measurements. | 1 day | 
| demonstrate safe surgical remove of lung nodule | no increased surgical morbidity from the operation | 30 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung nodule, lung cancer, lung mass