Active — Not RecruitingNot Applicable

LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

United States425 participantsStarted 2022-01-26

Plain-language summary

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

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
✓. Planned biopsy nodule of interest:
✓. is solid ≤3 cm; or
✓. is nonsolid, ground glass opacity, of any size; or
✓. is part solid, where the solid component is no larger than 3cm (maximum diameter).

✕. Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
✕. Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.

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

Timeframe: up to 60 days

NCT IDNCT05171491

SponsorLungLife AI

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-30