LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

NCT ID: NCT05171491

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-26

Study Completion Date

2024-09-02

Brief Summary

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

Detailed Description

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Conditions

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Solitary Pulmonary Nodule Multiple Pulmonary Nodules

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LungLife AI

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Donovan, MD

Role: STUDY_DIRECTOR

LungLife AI

Locations

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Clinical Site 04

Los Angeles, California, United States

Site Status

Clinical Site 05

Bay Pines, Florida, United States

Site Status

Clinical Site 03

Miami, Florida, United States

Site Status

Clinical Site 07

Hines, Illinois, United States

Site Status

Clinical Site 27

Kansas City, Kansas, United States

Site Status

Clinical Site 12

Wichita, Kansas, United States

Site Status

Clinical Site 08

Kansas City, Missouri, United States

Site Status

Clinical Site 18

Reno, Nevada, United States

Site Status

Clinical Site 01

New York, New York, United States

Site Status

Clinical Site 25

Columbia, South Carolina, United States

Site Status

Clinical Site 02

Houston, Texas, United States

Site Status

Clinical Site 32

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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LAI-001

Identifier Type: -

Identifier Source: org_study_id

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