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

M.D. Anderson Cancer Center

Status and phase: Withdrawn; Phase 2

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

Treatments: Drug: Indocyanine Green Solution; Procedure: Computed Tomography; Device: Therapeutic Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04987281

NCI-2021-05983 (Registry Identifier)

2021-0243 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Device feasibility (bronchoscopy, CT, indocyanine green)

Experimental group

Description:

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

Treatment:

Device: Therapeutic Bronchoscopy

Procedure: Computed Tomography

Drug: Indocyanine Green Solution