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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Metastatic Malignant Neoplasm in the Lung
• Intervention / Treatment: Procedure: Computed Tomography; Drug: Indocyanine Green Solution; Device: Therapeutic Bronchoscopy

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Drug: Indocyanine Green Solution; Given via injection; Other Names: IC-GREEN; ICG Solution; Device: Therapeutic Bronchoscopy; Undergo bronchoscopy using Ion robotic bronchoscope

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: David W Rice, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pharmaceutical Solutions
• Other Study ID Numbers: 2021-0243 (Other Identifier: M D Anderson Cancer Center); NCI-2021-05983 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes