Clinical trial · Observational
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
NCT01958931CI-TRIAL-00012357completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients Suspicious for Lung Cancer
- description
- Subjects are symptomatic of lung cancer and have one or more lung nodules or lung masses suspicious for lung cancer.
Primary outcomes (1)
- measure
- ProLung Test utility in lung cancer
- timeFrame
- date of conclusive diagnosis
- description
- 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 outcomes (1)
- measure
- Safety and Tolerability of the ProLung Test
- timeFrame
- within 30 minutes of the ProLung Test
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.