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A Multi-Center Trial of the ProLung Test™
Not Recruiting
Trial ID: NCT01566682
Purpose
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.
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
Stanford Investigator(s)
Meghan Ramsey
Clinical Associate Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
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.
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061