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A Multi-Center Trial of the ProLung Test™

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ClinicalTrials.gov Identifier: NCT01566682
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Solitary Pulmonary Nodule Multiple Pulmonary Nodules

Study Design

Study Type : Observational
Estimated Enrollment : 350 participants
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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Indeterminate Pulmonary Lesions
Patients with Pulmonary Lesions as seen by CT

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with pulmonary lesions suspicious for lung cancer

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566682

Contact: Michael A Garff, BS, MBA 8012049625 mag@prolungdx.com

United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024
Contact: John Dermand    310-206-0396    jdermand@mednet.ucla.edu   
Sub-Investigator: Denise Aberle, MD         
Sub-Investigator: Fereidoun Abtin, MD         
Principal Investigator: Igor Barjaktarevic, MD         
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Anne Powers, RN, MSN, FNP    858-449-7218    atpowers@ucsd.edu   
Principal Investigator: Samir Makani, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Karen Morris, PhD    650-497-2929    kkmorris@stanford.edu   
Contact: Kim Nguyen       kvnguyen@stanford.edu   
Principal Investigator: Arthur W Sung, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jessica Shore, PhD    708-216-2027    jshore@luc.edu   
Contact: Jeanne Cerceo    708-216-2058    jcerceo@luc.edu   
Principal Investigator: Amit Goyal, MD         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Towson, Maryland, United States, 21204
Contact: Steven Schmitt    443-849-3285    SSCHMITT@gbmc.org   
Principal Investigator: Rex Yung, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alichia Paton    617-784-3726    apaton@bidmc.harvard.edu   
Contact: Alexis Agnew    617-632-8386    aagnew1@bidmc.harvard.edu   
Principal Investigator: Adnan Majid, MD         
United States, Michigan
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48202
Contact: Roel Almario, R.N., B.S.N.    313-916-3558    ralmari1@hfhs.org   
Principal Investigator: Michael Simoff, MD         
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Patricia Grover, RN    612-672-5151    pgrover1@Fairview.org   
Contact: Kristen Nelson, RN    612-987-7148    knelso65@Fairview.org   
Principal Investigator: Ahmad Raza, MD         
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Amy Hensley    336-713-4747    ahensley@wakehealth.edu   
Contact: Dasonya Gibson    336-716-5601    dgibson@wakehealth.edu   
Principal Investigator: Clifford Howard, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425-6300
Contact: Savannah Miller    843-792-9873    Millesav@musc.edu   
Contact: Layne Walker    843-792-4557    Walkeram@musc.edu   
Principal Investigator: Gerard Silvestri, MD         
United States, Tennessee
University of Tennessee Withdrawn
Knoxville, Tennessee, United States, 37920
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Laila Noor    713-745-2645    LZNoor@mdanderson.org   
Principal Investigator: David Ost, MD         
Providence Health Center Recruiting
Waco, Texas, United States, 76712
Contact: Julia Armstrong, RN    245-751-4128    Julia.armstrong@phn-waco.org   
Principal Investigator: Boris Murillo, MD         
United States, Utah
Intermountain Healthcare Recruiting
Murray, Utah, United States, 84157
Contact: Mardee Merrill    801-507-4608    mardee.merrill@imail.org   
Principal Investigator: Denitza Blagev, MD         
Huntsman Cancer Institute Active, not recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Fresh Medical Laboratories
Huntsman Cancer Institute
University of California, Los Angeles
Henry Ford Health System
University of California, San Diego
Intermountain Health Care, Inc.
M.D. Anderson Cancer Center
Greater Baltimore Medical Center
Stanford University
Loyola University
Providence Health Center
Wake Forest
University of Minnesota Masonic Cancer Center
Beth Israel Deaconess Medical Center
Medical University of South Carolina
More Information

Responsible Party: Fresh Medical Laboratories
ClinicalTrials.gov Identifier: NCT01566682     History of Changes
Other Study ID Numbers: PL-208
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fresh Medical Laboratories:
Lung Lesion
Lung Mass
Lung Nodule
Lung Cancer
Low-Dose CT

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases