Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Robotic assisted bronchoscopy

Septimiu Murgu, MD

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.

Individual components of the primary endpoint

Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer

Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples

Auris Health, Inc.

The intervention to be administered is the placement of the microdevice containing 19 FDA-approved drugs into the lung lesion and the device's subsequent surgical resection. All study subjects will receive this same intervention; there is only one arm.

The microdevice containing 19 FDA-approved chemotherapeutic agents will be placed in the suspected tumor tissue at the time of surgical resection. Multiple chemotherapeutic agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study.

Microdevice loaded with 19 chemotherapeutic agents

Yolonda L Colson, MD, PhD

This is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. The microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. This will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.

The initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. The microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. Multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. The investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. Investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes.

Microdevice for Evaluating Drug Response in Site in Lung Lesions

Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions

Safety will be measured quantitatively by the number of participants with treatment-related adverse events.

Feasibility will be based on the ability to retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of the device reservoirs.

This initial proof-of-concept pilot study will gauge the ability of using the microdevice to predict tumor drug response, allowing a stratified systemic treatment to prioritize those agents inducing the greatest anti-tumor response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung	NCT04182815	Pulmonary Nodul... Lung Cancer	Robotic assiste...	21 Years -	Auris Health, Inc.
Microdevice for Evaluating Drug Response in Site in Lung Lesions	NCT03972228	Lung Tumor Lung Cancer	Microdevice loa...	18 Years -	Brigham and Women's Hospital
Microdevice for Evaluating Drug Response in Site in Lung Lesions	NCT03972228	Lung Tumor Lung Cancer	Microdevice loa...	18 Years -	Brigham and Women's Hospital
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung	NCT04182815	Pulmonary Nodul... Lung Cancer	Robotic assiste...	21 Years -	Auris Health, Inc.

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