Trial Outcomes & Findings for A Multi-Center Trial of the ProLung Test™ (NCT NCT01566682)

Last Updated: 2019-09-04

Results Overview

Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.

Recruitment status

COMPLETED

Target enrollment

420 participants

Primary outcome timeframe

The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Results posted on

2019-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Indeterminate Pulmonary Lesions Patients with Pulmonary Lesions as seen by CT
Overall Study STARTED	420
Overall Study COMPLETED	374
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center Trial of the ProLung Test™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indeterminate Pulmonary Lesions n=174 Participants Patients with Pulmonary Lesions as seen by CT
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=93 Participants
Age, Categorical >=65 years	103 Participants n=93 Participants
Sex: Female, Male Female	92 Participants n=93 Participants
Sex: Female, Male Male	82 Participants n=93 Participants
Race/Ethnicity, Customized Race · White	131 Participants n=93 Participants
Race/Ethnicity, Customized Race · Hispanic	15 Participants n=93 Participants
Race/Ethnicity, Customized Race · Indian	1 Participants n=93 Participants
Race/Ethnicity, Customized Race · East Indian	1 Participants n=93 Participants
Race/Ethnicity, Customized Race · Black	19 Participants n=93 Participants
Race/Ethnicity, Customized Race · Asian	6 Participants n=93 Participants
Race/Ethnicity, Customized Race · Unkown	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Population: Validation set of patients with indeterminate lung nodules

Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.

Outcome measures

Outcome measures
Measure	Indeterminate Pulmonary Lesions n=174 Participants Patients with Pulmonary Lesions as seen by CT
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions Positive Predictive Value	70.37 percentage Interval 60.82 to 78.77
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions Negative Predictive Value	46.97 percentage Interval 34.56 to 59.66
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions Sensitvity	68.47 percentage Interval 58.96 to 76.96
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions Specificity	49.21 percentage Interval 36.38 to 62.11

Adverse Events

Indeterminate Pulmonary Lesions

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Indeterminate Pulmonary Lesions n=420 participants at risk Patients with Pulmonary Lesions as seen by CT
Product Issues Discomfort at Device Measurement Location	0.71% 3/420 • Number of events 3 • Adverse events were collected and reported on the day of measurement by the Study Device

Additional Information

Michael Garff, Chief Operating Officer

ProLung

Phone: 8012049625

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place