A Multi-Center Trial of the ProLung Test™

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.

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Key information

Conditions

Solitary Pulmonary Nodule Disease Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Medical Center, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who meet all of the following criteria may be enrolled in this Study:

Subject is male or female, age 18 or older.
Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.
Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
Subject meets one or more of the following conditions:

indicated for a tissue biopsy
indicated for surgical resection of the lung
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).
Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
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:

Subject has an implanted electronic device in the chest.
Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
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.
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.
Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
Subject will have undergone unusually strenuous exercise within 24 hours.
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.

Treatment and study plan

Primary outcomes

Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions

Time frame: 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.

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

Sponsors and collaborators

Lead sponsor

Fresh Medical Laboratories

Industry

Collaborators

Beth Israel Deaconess Medical Center
Greater Baltimore Medical Center
Henry Ford Health System
Huntsman Cancer Institute
Intermountain Health Care, Inc.
Loyola University
M.D. Anderson Cancer Center
Masonic Cancer Center, University of Minnesota
Medical University of South Carolina
Providence Health Center
Stanford University
University of California, Los Angeles
University of California, San Diego
Wake Forest

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2019
First posted: Mar 29, 2012
Registry last updated: Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed