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:
- Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with tissue diagnosis.
- Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive tissue patient diagnosis.
- 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.
Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Clinical Efficacy in the risk stratification of patients with indeterminate lesions [ Time Frame: The ProLung Test will be performed on patients prior to their indicated biopsy and evaluated against conclusive post biopsy pathology results ] [ Designated as safety issue: Yes ]Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicous for lung cancer.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients with Pulmonary Lesions
Patients with Pulmonary Lesions as seen by CT
|Contact: Michael A Garff, BS, MBAfirstname.lastname@example.org|
|United States, California|
|LA, California, United States, 90024|
|Contact: Polly Kay, R.N. 310-794-0376 email@example.com|
|Contact: Andrea Oh, MD 3107948956 firstname.lastname@example.org|
|Sub-Investigator: Denise Aberle, MD|
|Principal Investigator: Fereidoun Abtin, MD|
|United States, Michigan|
|Henry Ford Medical Center||Not yet recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Marcie Major, R.N., B.S.N. 313-916-2433 MMAJOR1@hfhs.org|
|Contact: Michael Simoff, MD 313-916-2433 email@example.com|
|Principal Investigator: Michael Simoff, MD|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|SLC, Utah, United States, 84112|
|Contact: Nicole Mauerman, MS 801-587-3095 firstname.lastname@example.org|
|Principal Investigator: Chakravarthy Reddy, MD|
|Principal Investigator:||Rex C Yung, MD||Johns Hopkins Medical Center|
|Principal Investigator:||Denise R. Aberle, MD||UCLA Radiological Sciences Section of Thoracic Imaging|
|Principal Investigator:||Chakravarthy Reddy, MD||Huntsman Cancer Institute|
|Principal Investigator:||Michael Simoff, MD||Henry Ford Health System|