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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2023-12-27

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Device feasibility (bronchoscopy, CT, indocyanine green)

During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Indocyanine Green Solution

Intervention Type DRUG

Given via injection

Therapeutic Bronchoscopy

Intervention Type DEVICE

Undergo bronchoscopy using Ion robotic bronchoscope

Interventions

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Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Indocyanine Green Solution

Given via injection

Intervention Type DRUG

Therapeutic Bronchoscopy

Undergo bronchoscopy using Ion robotic bronchoscope

Intervention Type DEVICE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT Scan tomography IC-GREEN ICG Solution

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