Solitary Pulmonary Nodule Clinical Trial
Official title:
Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
| NCT number | NCT05171491 |
| Other study ID # | LAI-001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 26, 2021 |
| Est. completion date | June 2023 |
| Verified date | November 2022 |
| Source | LungLife AI |
| Contact | Brad McCoy |
| Phone | 805-409-9868 |
| bmccoy[@]lunglifeai.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
| Status | Recruiting |
| Enrollment | 425 |
| Est. completion date | June 2023 |
| Est. primary completion date | June 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Site 05 | Bay Pines | Florida |
| United States | Clinical Site 25 | Columbia | South Carolina |
| United States | Clinical Site 07 | Hines | Illinois |
| United States | Clinical Site 02 | Houston | Texas |
| United States | Clinical Site 08 | Kansas City | Missouri |
| United States | Clinical Site 27 | Kansas City | Kansas |
| United States | Clinical Site 04 | Los Angeles | California |
| United States | Clinical Site 03 | Miami | Florida |
| United States | Clinical Site 32 | Milwaukee | Wisconsin |
| United States | Clinical Site 01 | New York | New York |
| United States | Clinical Site 18 | Reno | Nevada |
| United States | Clinical Site 12 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| LungLife AI |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. | up to 60 days | ||
| Secondary | Evaluate Clinical Variables With and Without LungLB Test Results | 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. | up to 60 days |
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