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Brief Title: A Multi-Center Trial of the ProLung Test™
Official 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
Study ID: NCT01566682
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Medical Center, Los Angeles, California, United States
UCSD Medical Center, San Diego, California, United States
Stanford University Medical Center, Stanford, California, United States
Loyola University Medical Center, Maywood, Illinois, United States
Greater Baltimore Medical Center, Towson, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Henry Ford Medical Center, Detroit, Michigan, United States
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
Providence Health Center, Waco, Texas, United States
Intermountain Healthcare, Murray, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States