Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Conditions
Keywords
Lung Lesion, Lung Mass, Lung Nodule, Lung Cancer, Low-Dose CT, CT, Diagnostic, Evaluation, Bioconductance, ProLung
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. 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.
Interventions
None listed
Sponsors
Huntsman Cancer Institute
University of California, Los Angeles
Henry Ford Health System
University of California, San Diego
Intermountain Health Care, Inc.
M.D. Anderson Cancer Center
Greater Baltimore Medical Center
Stanford University
Loyola University
Providence Health Center
Wake Forest
University of Minnesota Masonic Cancer Center
Beth Israel Deaconess Medical Center
Medical University of South Carolina
Fresh Medical Laboratories
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions | 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. | Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indeterminate Pulmonary Lesions Patients with Pulmonary Lesions as seen by CT | 174 |
| Total | 174 |
Baseline characteristics
| Characteristic | Indeterminate Pulmonary Lesions |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 103 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Race/Ethnicity, Customized Race Asian | 6 Participants |
| Race/Ethnicity, Customized Race Black | 19 Participants |
| Race/Ethnicity, Customized Race East Indian | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic | 15 Participants |
| Race/Ethnicity, Customized Race Indian | 1 Participants |
| Race/Ethnicity, Customized Race Unkown | 1 Participants |
| Race/Ethnicity, Customized Race White | 131 Participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 420 |
| other Total, other adverse events | 3 / 420 |
| serious Total, serious adverse events | 0 / 420 |
Outcome results
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.
Time frame: 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.
Population: Validation set of patients with indeterminate lung nodules
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indeterminate Pulmonary Lesions | Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions | Positive Predictive Value | 70.37 percentage |
| Indeterminate Pulmonary Lesions | Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions | Negative Predictive Value | 46.97 percentage |
| Indeterminate Pulmonary Lesions | Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions | Sensitvity | 68.47 percentage |
| Indeterminate Pulmonary Lesions | Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions | Specificity | 49.21 percentage |