LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

LungLife AI

Status: Active, not recruiting

Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Study type: Observational

Funder types: Industry

Identifiers

NCT05171491

LAI-001

Details and patient eligibility

About

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

Enrollment: 425 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

425 participants in 1 patient group

Indeterminate Lung Nodule

Description:

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