A Multi-Center Trial of the ProLung Test™

This study is currently recruiting participants.
Verified February 2014 by Fresh Medical Laboratories
Sponsor:
Collaborators:
Huntsman Cancer Institute
University of California, Los Angeles
Henry Ford Health System
Information provided by (Responsible Party):
Fresh Medical Laboratories
ClinicalTrials.gov Identifier:
NCT01566682
First received: March 27, 2012
Last updated: February 21, 2014
Last verified: February 2014

March 27, 2012
February 21, 2014
October 2012
December 2014   (final data collection date for primary outcome measure)
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 suspicious for lung cancer.
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Complete list of historical versions of study NCT01566682 on ClinicalTrials.gov Archive Site
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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 tissue diagnosis.
  2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive tissue 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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Subjects with pulmonary lesions suspicious for lung cancer

  • Solitary Pulmonary Nodule
  • Multiple Pulmonary Nodules
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Patients with Pulmonary Lesions
Patients with Pulmonary Lesions as seen by CT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2014   (final data collection date for primary outcome measure)

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 of the lung
    • indicated for surgical resection of the lung
    • being followed by CT for nodule growth within a 1-year time frame*

      • subject must receive at least one follow-up CT by their 1-year enrollment anniversary or within 60 days after their 1-year enrollment anniversary to continue in the Study.
  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 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.
Both
18 Years and older
No
Contact: Michael A Garff, BS, MBA 8012049625 mag@prolung.com
United States
 
NCT01566682
PL-208
Yes
Fresh Medical Laboratories
Fresh Medical Laboratories
  • Huntsman Cancer Institute
  • University of California, Los Angeles
  • Henry Ford Health System
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
Fresh Medical Laboratories
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP