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LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Sponsor
LungLife AI (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05171491
Collaborator
(none)
425
Enrollment
5
Locations
28.1
Anticipated Duration (Months)
85
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    425 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
    Actual Study Start Date :
    Jan 26, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Indeterminate Lung Nodule

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

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. [up to 60 days]

    Secondary Outcome Measures

    1. Evaluate Clinical Variables With and Without LungLB Test Results [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. is solid ≤3 cm; or

    4. is nonsolid, ground glass opacity, of any size; or

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bay Pines VA Healthcare System Bay Pines Florida United States 33744
    2 Wichita VA Healthcare System Wichita Kansas United States 67218
    3 Kansas City VA Medical Center Kansas City Missouri United States 64128
    4 Icahn School of Medicine at Mt. Sinai New York New York United States 10029
    5 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • LungLife AI

    Investigators

    • Study Director: Michael Donovan, MD, LungLife AI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LungLife AI
    ClinicalTrials.gov Identifier:
    NCT05171491
    Other Study ID Numbers:
    • LAI-001
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LungLife AI
    Lung Cancer
    Circulating Genetically Abnormal Cells (CGAC)
    4-color FISH
    Increased/Decreased Risk
    Early Lung Cancer Detection
    Indeterminate Nodule
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Solitary Pulmonary Nodule

    Study Results

    No Results Posted as of Jul 28, 2022