Completed

A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Solitary Pulmonary Nodule+9

+ Disease

+ Lung Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorFresh Medical Laboratories
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result. There are three Specific Aims of this study: 1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis. 2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis. 3. Assess the safety and tolerability of the ProLung Test procedures. Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.

Official TitleA Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer
Principal SponsorFresh Medical Laboratories
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

420 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Solitary Pulmonary NoduleDiseaseLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SitePathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic NeoplasmsMultiple Pulmonary Nodules

Criteria

Inclusion Criteria: Subjects who meet all of the following criteria may be enrolled in this Study: 1. Subject is male or female, age 18 or older. 2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer. 3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging. 4. Subject meets one or more of the following conditions: * indicated for a tissue biopsy * indicated for surgical resection of the lung 5. Subject must be able to receive a ProLung Test * within 60 days of abnormal CT (Inclusion Criterion 2 \& 3) * within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4). 6. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol. 7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF"). Exclusion Criteria The following criteria will disqualify a subject from enrollment into this Study: 1. Subject has an implanted electronic device in the chest. 2. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis. 3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules. 4. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure. 5. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement. 6. Subject will have undergone unusually strenuous exercise within 24 hours. 7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

UCLA Medical Center

Los Angeles, United StatesOpen UCLA Medical Center in Google Maps
Suspended

UCSD Medical Center

San Diego, United States
Suspended

Stanford University Medical Center

Stanford, United States
Suspended

Loyola University Medical Center

Maywood, United States
Completed15 Study Centers