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

Phase 2

Withdrawn

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

Interventions: Procedure: Computed Tomography
Drug: Indocyanine Green Solution
Device: Therapeutic Bronchoscopy

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Device feasibility (bronchoscopy, CT, indocyanine green)	Computed Tomography	During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
Device feasibility (bronchoscopy, CT, indocyanine green)	Indocyanine Green Solution	During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
Device feasibility (bronchoscopy, CT, indocyanine green)	Therapeutic Bronchoscopy	During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.

Primary Outcome Measures

Name	Time	Method
Number of successful procedures out of 50	through study completion, an average of 1 year	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 \[CT\]).

Secondary Outcome Measures

Name	Time	Method
Closest margin on resected nodule pathology	Up to 2 years
Indocyanine green visualized during robotic pulmonary resection	through study completion, an average of 1 year
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	Up to 2 years	Evaluated using rapid cytology.
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
Proximity of needle to the lesion on first deployment	through study completion, an average of 1 year	Evaluated retrospectively by research fellow using cone beam CT images.

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