LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Active, not recruiting

• Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

• Registration Number: NCT05171491
• Lead Sponsor: LungLife AI

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Study Start: 2022-01-26
• Primary Completion: 2023-12-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Study Completion: 2024-09-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 425

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Clinical Site 07; 🇺🇸 Hines, Illinois, United States

Clinical Site 01; 🇺🇸 New York, New York, United States

Clinical Site 04; 🇺🇸 Los Angeles, California, United States

Clinical Site 25; 🇺🇸 Columbia, South Carolina, United States

Clinical Site 12; 🇺🇸 Wichita, Kansas, United States

Clinical Site 18; 🇺🇸 Reno, Nevada, United States

Clinical Site 05; 🇺🇸 Bay Pines, Florida, United States

Clinical Site 02; 🇺🇸 Houston, Texas, United States

Clinical Site 27; 🇺🇸 Kansas City, Kansas, United States

Clinical Site 03; 🇺🇸 Miami, Florida, United States

Clinical Site 32; 🇺🇸 Milwaukee, Wisconsin, United States

Clinical Site 08; 🇺🇸 Kansas City, Missouri, United States