LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Study Details
Study Description
Brief Summary
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
Condition or Disease | Intervention/Treatment | Phase |
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|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Indeterminate Lung Nodule Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care. |
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. [up to 60 days]
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
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Planned biopsy nodule of interest:
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is solid ≤3 cm; or
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is nonsolid, ground glass opacity, of any size; or
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is part solid, where the solid component is no larger than 3cm (maximum diameter).
Exclusion Criteria:
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Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
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Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bay Pines VA Healthcare System | Bay Pines | Florida | United States | 33744 |
2 | Wichita VA Healthcare System | Wichita | Kansas | United States | 67218 |
3 | Kansas City VA Medical Center | Kansas City | Missouri | United States | 64128 |
4 | Icahn School of Medicine at Mt. Sinai | New York | New York | United States | 10029 |
5 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- LungLife AI
Investigators
- Study Director: Michael Donovan, MD, LungLife AI
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LAI-001