Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Conditions
Brief summary
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
Detailed description
This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung Test when used to evaluate patients with a positive CT scan for lung cancer.
Interventions
None listed
Sponsors
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
* Subject is male or female, age 18 or above. * If female, subject * is of non-childbearing potential meaning permanently sterile, or * is one year post-menopausal; or * is not pregnant as confirmed by negative urine pregnancy test and using adequate birth control at time of screening. * Subject presents with one or more of the following clinical symptoms or suspicious radiological finding(s): * Persistent cough * Hoarseness * Shortness of breath * Sputum streaked with blood * Fatigue * Unexplained recent weight loss * Recurrent pneumonia or bronchitis * Chest pain * Abnormal chest radiograph * Subject has undergone a CT scan of the lungs within 44 days of measurement that indicates one or more non-calcified nodules (NCN) or lung masses suspicious for lung cancer. * Subject is capable of understanding and agreeing to fulfill the requirements of this protocol. * Subject has signed the IRB/IEC approved informed consent form.
Exclusion criteria
• Subjects who meet one or more of the following criteria may not be enrolled in this Study: * Subject has a pacemaker or other implanted electronic device. * Subject with diagnosed malignancy within the past 5 (five) years except for non-melanoma skin cancer. * Subject with significant systemic diseases including uncontrolled diabetes, severe heart failure, uncontrolled hypertension, myocardial infarction and/or auto-immune conditions within the prior 3 (three) months. * Subject taking systemic corticosteroid medication (except for inhaled) within 14 days prior to measurement session. * Subject has had an invasive medical procedure that involves the thoracic cavity within 30 days prior to the measurement session. * Subject who currently abuses alcohol or drugs. * Subject presents with an anomalous physical or anatomical condition that precludes measurement. * Subject will have undergone unusually strenuous exercise within 24 hours prior to measurement session. * Subject who has, in the Principal Investigator's opinion, any medical condition or other circumstance that would prevent completion of this Study or interfere with analysis of the Study results. * Subjects who have undergone radiation and chemotherapy treatment within the past 30 days. * Subject receiving therapy for documented or suspected chest infection. * Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ProLung Test utility in lung cancer | date of conclusive diagnosis | This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan to determine whether it is appropriate to be used in a pivotal study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of the ProLung Test | within 30 minutes of the ProLung Test | This Study will assess whether there are any potential safety concerns of the ProLung Test when used to evaluate patients with a positive CT scan for lung cancer. |
Countries
United States
Outcome results
None listed