LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

N/AActive Not RecruitingNCT05171491

LungLife AI425 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

425

Conditions

Solitary Pulmonary Nodule Multiple Pulmonary Nodules

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (12)

Clinical Site 04

Los Angeles, California, United States

Clinical Site 05

Bay Pines, Florida, United States

Clinical Site 03

Miami, Florida, United States

Outcomes

Primary Outcomes

Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.

Time frame: up to 60 days

Secondary Outcomes

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.

Time frame: up to 60 days

Data from ClinicalTrials.gov

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