LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

June 11, 2024 updated by: LungLife AI

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

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Time Frame: up to 60 days
up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Clinical Variables With and Without LungLB Test Results
Time Frame: up to 60 days
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

This is where you will find people and organizations involved with this study.

Sponsor

LungLife AI

Investigators

  • Study Director: Michael Donovan, MD, LungLife AI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

September 2, 2024

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)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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