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

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Pulmonary Nodule
• Intervention / Treatment: Device: Robotic assisted bronchoscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 691

Contacts and Locations

• Study Contact: Name: Damaris Pederson; Phone Number: 619-708-2607; Email: dpadin@its.jnj.com
• Study Contact Backup: Name: Jaime Connelly; Phone Number: 513-284-8104; Email: JConnel8@its.jnj.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network
• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Prince of Wales Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Encinitas, California, United States, 92024
      • Costal Pulmonary Associates
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • The University of Connecticut Health Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine
    • Winfield, Illinois, United States, 60190
      • Northwestern Medicine Central DuPage Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota Lung Center, Ltd
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Cancer Institute
  • Ohio
    • Cleveland, Ohio, United States, 931531
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Clinical Research Associates of Central PA
    • Erie, Pennsylvania, United States, 16550
      • University of Pittsburgh Medical Center, Hamot
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.

Description

Inclusion Criteria:

1. Over 21 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

Exclusion Criteria:

1. Medical contraindication to bronchoscopy as assessed by the investigator
2. Presence of uncorrectable bleeding disorders
3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
4. Patients with the target lesion having endobronchial involvement seen on chest CT
5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
7. Uncontrolled or irreversible coagulopathy;
8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
9. CT scan done greater than 28 days before the bronchoscopy procedure.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic assisted bronchoscopy; Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.	Device: Robotic assisted bronchoscopy; Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.; Other Names: Robotic assisted bronchoscopy with Monarch platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device or procedure related complications	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.	up to 7 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device or procedure related complications	Individual components of the primary endpoint	up to 7 days post procedure
Rate of all pneumothoraxes		up to 7 days post procedure
Total procedure time		During the procedure
Rate of conversion to conventional bronchoscopic procedure		During the procedure
Rate of adverse events unrelated to device or procedure		up to 7 days post procedure
Stage at diagnosis	Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer	up to 24 months post procedure
Diagnostic yield	Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples	up to 24 months post procedure
Sensitivity for malignancy		up to 24 months post procedure
Rate of post-bronchoscopy infections		up to 7 days post-procedure

Collaborators and Investigators

• Sponsor: Auris Health, Inc.
• Investigators: Principal Investigator: Septimiu Murgu, MD, University of Chicago

Publications and helpful links

General Publications

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; Bronchoscopy; Robotic bronchoscopy; Lung Lesions; Peripheral lesions; Monarch
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 19-BR-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No