A Multi-Center Trial of the ProLung Test™

NCT01566682 | Completed Results

• 1 other identifier: PL-208
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 15

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. 1.Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
2. 2.Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
3. 3.Assess the safety and tolerability of the ProLung Test procedures.

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Keywords

Lung Lesion; Lung Mass; Lung Nodule; Lung Cancer; Low-Dose CT; CT; Diagnostic; Evaluation; Bioconductance; ProLung

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Indeterminate Pulmonary Lesions

Patients with Pulmonary Lesions as seen by CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with pulmonary lesions suspicious for lung cancer

You may qualify if:

• Subjects who meet all of the following criteria may be enrolled in this Study:
• Subject is male or female, age 18 or older.
• Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.
• Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
• Subject meets one or more of the following conditions:
• indicated for a tissue biopsy
• indicated for surgical resection of the lung
• Subject must be able to receive a ProLung Test
• Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
• Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

You may not qualify if:

• The following criteria will disqualify a subject from enrollment into this Study:
• Subject has an implanted electronic device in the chest.
• Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
• 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.
• 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.
• Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
• Subject will have undergone unusually strenuous exercise within 24 hours.
• 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.

Sponsors & Collaborators

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

Study Sites (15)

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Greater Baltimore Medical Center

Towson, Maryland, 21204, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-6300, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

Intermountain Healthcare

Murray, Utah, 84157, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Garff, Chief Operating Officer
• Organization: ProLung

mag@prolunginc.com

8012049625

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 4, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)