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Clinical Trials/NCT05171491
NCT05171491Active, not recruitingNot Applicable

Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

LungLife AI12 sites in 1 country425 target enrollmentStarted: January 26, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
425
Locations
12
Primary Endpoint
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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.

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(up to 60 days)

Investigators

Sponsor
LungLife AI
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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