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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01566682
Other study ID # PL-208
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date March 2019

Study information

Verified date August 2019
Source Fresh Medical Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Henry Ford Medical Center Detroit Michigan
United States MD Anderson Cancer Center Houston Texas
United States UCLA Medical Center Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States University of Minnesota Masonic Cancer Center Minneapolis Minnesota
United States Intermountain Healthcare Murray Utah
United States Mayo Clinic Rochester Minnesota
United States Huntsman Cancer Institute Salt Lake City Utah
United States UCSD Medical Center San Diego California
United States Stanford University Medical Center Stanford California
United States Greater Baltimore Medical Center Towson Maryland
United States Providence Health Center Waco Texas
United States Wake Forest University Winston-Salem North Carolina

Sponsors (15)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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