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NCT04987281 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2024-10-23
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
Interventions
- PROCEDURE
-
Computed Tomography
Undergo CT
- DRUG
-
Indocyanine Green Solution
Given via injection
- DEVICE
-
Therapeutic Bronchoscopy
Undergo bronchoscopy using Ion robotic bronchoscope
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
David W Rice · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-26
- Primary Completion
- 2023-12-27
- Completion
- 2023-12-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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