A Multi-Center Trial of the ProLung Test™

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Medical Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Maryland
    • Towson, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Cancer Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • South Carolina
    • Charleston, South Carolina, United States, 29425-6300
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Waco, Texas, United States, 76712
      • Providence Health Center
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Healthcare
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with pulmonary lesions suspicious for lung cancer

Description

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

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Indeterminate Pulmonary Lesions; Patients with Pulmonary Lesions as seen by CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions	Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Lung Cancer; Evaluation; CT; Diagnostic; Lung Lesion; Lung Mass; Lung Nodule; Low-Dose CT; Bioconductance; ProLung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: PL-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No