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

NCT04987281 | Withdrawn Phase 2 DMC FDA Device

• 2 other identifiers: 2021-0243NCI-2021-05983
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (1)

Device feasibility (bronchoscopy, CT, indocyanine green)

EXPERIMENTAL

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

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

Interventions

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Device feasibility (bronchoscopy, CT, indocyanine green)

Indocyanine Green Solution DRUG

Given via injection

Also known as: IC-GREEN, ICG Solution

Device feasibility (bronchoscopy, CT, indocyanine green)

Therapeutic Bronchoscopy DEVICE

Undergo bronchoscopy using Ion robotic bronchoscope

Device feasibility (bronchoscopy, CT, indocyanine green)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Serum creatinine \> 2.0
• Central lesions
• Iodide allergy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David W Rice

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: August 3, 2021
• Study Start: January 26, 2022
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: October 23, 2024

Record last verified: 2023-12

Locations

US (1)