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

Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04987281
• Other study ID #: 2021-0243
• Secondary ID: NCI-2021-0598320
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 26, 2022
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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:

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo CT

Drug:
• Indocyanine Green Solution
Given via injection

Device:
• Therapeutic Bronchoscopy
Undergo bronchoscopy using Ion robotic bronchoscope

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of repositions required to deploy needle into lesion		through study completion, an average of 1 year
Secondary	Presence or absence of diagnostic tissue in sample	Evaluated using rapid cytology.	Up to 2 years
Secondary	Indocyanine green visualized during robotic pulmonary resection		through study completion, an average of 1 year
Secondary	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
Secondary	Closest margin on resected nodule pathology		Up to 2 years
Secondary	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

External Links

•   MD Anderson Cancer Center