LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Correlate performance of LungLB Test with outcome of a scheduled biopsy.

Study Overview

• Status: Recruiting
• Conditions: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

• Study Type: Observational
• Enrollment (Anticipated): 425

Contacts and Locations

• Study Contact: Name: Brad McCoy; Phone Number: 805-409-9868; Email: bmccoy@lunglifeai.com
• Study Contact Backup: Name: Lara Baden; Email: lbaden@lunglifeai.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Clinical Site 04
      • Principal Investigator: Medical Doctor
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Recruiting
      • Clinical Site 05
      • Principal Investigator: Medical Doctor
    • Miami, Florida, United States, 33136
      • Recruiting
      • Clinical Site 03
      • Principal Investigator: Medical Doctor
  • Illinois
    • Hines, Illinois, United States, 60141
      • Recruiting
      • Clinical Site 07
      • Principal Investigator: Medical Doctor
  • Kansas
    • Kansas City, Kansas, United States, 64111
      • Recruiting
      • Clinical Site 27
      • Principal Investigator: Medical Doctor
    • Wichita, Kansas, United States, 67218
      • Recruiting
      • Clinical Site 12
      • Principal Investigator: Medical Doctor
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Recruiting
      • Clinical Site 08
      • Principal Investigator: Medical Doctor
  • Nevada
    • Reno, Nevada, United States, 89502
      • Suspended
      • Clinical Site 18
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Clinical site 01
      • Principal Investigator: Medical Doctor
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Clinical Site 25
      • Principal Investigator: Medical Doctor
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Clinical Site 02
      • Principal Investigator: Medical Doctor
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Recruiting
      • Clinical Site 32
      • Principal Investigator: Medical Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with suspicious indeterminate pulmonary nodules identified incidentally or through a lung cancer screening program. up to 15 institutions geographically distributed across the US.

Description

Inclusion Criteria:

1. At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.

2. Planned biopsy nodule of interest:

   1. is solid ≤3 cm; or
   2. is nonsolid, ground glass opacity, of any size; or
   3. is part solid, where the solid component is no larger than 3cm (maximum diameter).

Exclusion Criteria:

1. Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
2. Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.

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
Indeterminate Lung Nodule; Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.	up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Clinical Variables With and Without LungLB Test Results	Evaluate the independent and associated contribution of readily available clinical variables including age, race, gender, socioeconomic level, environmental exposure, tobacco use, and radiology data combined with and without the LungLB test results and correlate with biopsy (tissue / FNA) outcome of indeterminate pulmonary nodules.	up to 60 days

Collaborators and Investigators

• Sponsor: LungLife AI
• Investigators: Study Director: Michael Donovan, MD, LungLife AI

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Lung Cancer; Circulating Genetically Abnormal Cells (CGAC); 4-color FISH; Increased/Decreased Risk; Early Lung Cancer Detection; Indeterminate Nodule
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: LAI-001

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: No
• product manufactured in and exported from the U.S.: No