Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer

Solitary Pulmonary Nodule Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958931
• Other study ID #: FML - 204
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 8, 2013
• Start date: September 2007
• Est. completion date: January 2011

Study information

• Verified date: October 2013
• Source: Fresh Medical Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Fresh Medical Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ProLung Test utility in lung cancer	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.	date of conclusive diagnosis	No
Secondary	Safety and Tolerability 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.	within 30 minutes of the ProLung Test	Yes