Robotic Bronchoscopy With Cone CT and Indocyanine Green to Aid Removal of Lung Lesions in Patients With Stage I Non-small Cell Lung Cancer or Lung Metastases, REPLACING Study

Study Overview
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Brief Summary
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This phase II trial studies the use of Ion robotic bronchoscope with a mobile computed tomography (CT) scanner to biopsy tumors and inject a fluorescent dye called indocyanine green to mark the tumor during surgery in patients with stage I non-small cell lung cancer or cancer that has spread to the lung (lung metastases). Sometimes small tumors or those that are not on the surface of the lung can be challenging to remove without making larger incisions. Injecting the dye, may help doctors see the tumor more easily, which may allow for smaller incisions and by being able to see the tumor, doctors may be better able to decide where to make the incisions in order to get all of the tumor out.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the feasibility of using the Ion Endoluminal Platform (IEP; Intuitive, Sunnyvale, California [CA]) with the Cios Spin - a mobile cone-beam C - (Siemens Medical Solutions, Malvern, Pennsylvania [PA], United States [US]) in the operating room setting. OUTLINE: During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.

Official Title
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Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study

Conditions
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Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: Indocyanine Green Solution
* Device: Therapeutic Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Medically operable Undergoing pulmonary resection for either stage I non-small cell lung cancer (NSCLC) (undergoing segmentectomy) or metastatic disease to the lung Lesions < 2cm in longest diameter Lesions are located at least 1cm from the pleura Exclusion Criteria: Pregnant Serum creatinine > 2.0 Central lesions Iodide allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Device feasibility (bronchoscopy, CT, indocyanine green)<br>During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection. | Procedure: Computed Tomography<br>* Undergo CT<br>* Other names: tomography;Drug: Indocyanine Green Solution<br>* Given via injection<br>* Other names: ICG Solution;Device: Therapeutic Bronchoscopy<br>* Undergo bronchoscopy using Ion robotic bronchoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful procedures out of 50 | Success is defined as the ability of the provider to navigate to the lesion and deploy the needle into the lesion using the three allotted scans to aid in targeting to the lesion (As evaluated by surgeon using cone beam computed tomography [CT]). | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of repositions required to deploy needle into lesion |  | through study completion, an average of 1 year | 
| Presence or absence of diagnostic tissue in sample | Evaluated using rapid cytology. | Up to 2 years | 
| Indocyanine green visualized during robotic pulmonary resection |  | through study completion, an average of 1 year | 
| Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule |  | through study completion, an average of 1 year | 
| Closest margin on resected nodule pathology |  | Up to 2 years | 
| Proximity of needle to the lesion on first deployment | Evaluated retrospectively by research fellow using cone beam CT images. | through study completion, an average of 1 year |