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NCT05171491 Clinical Trial

LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Solitary Pulmonary Nodule Clinical Trial

Official title:
Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05171491
Other study ID # LAI-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 26, 2022
Est. completion date September 2, 2024

Study information
Verified date June 2024
Source LungLife AI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 425
Est. completion date September 2, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Clinical Site 05 Bay Pines Florida
United States Clinical Site 25 Columbia South Carolina
United States Clinical Site 07 Hines Illinois
United States Clinical Site 02 Houston Texas
United States Clinical Site 08 Kansas City Missouri
United States Clinical Site 27 Kansas City Kansas
United States Clinical Site 04 Los Angeles California
United States Clinical Site 03 Miami Florida
United States Clinical Site 32 Milwaukee Wisconsin
United States Clinical Site 01 New York New York
United States Clinical Site 18 Reno Nevada
United States Clinical Site 12 Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
LungLife AI

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. up to 60 days
Secondary 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
See also
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