Clinical trial · Observational
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
NCT05171491CI-TRIAL-00077944unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Indeterminate Lung Nodule
- description
- Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care.
Primary outcomes (1)
- measure
- Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
- timeFrame
- up to 60 days
Secondary outcomes (1)
- measure
- Evaluate Clinical Variables With and Without LungLB Test Results
- timeFrame
- up to 60 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.