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

Sponsor
Fresh Medical Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01958931
Collaborator
(none)
55
Enrollment
1
Location
40
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    55 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2007
    Actual Primary Completion Date :
    Nov 1, 2008
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Patients Suspicious for Lung Cancer

    Subjects are symptomatic of lung cancer and have one or more lung nodules or lung masses suspicious for lung cancer.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins School of Medicine Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Fresh Medical Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fresh Medical Laboratories
    ClinicalTrials.gov Identifier:
    NCT01958931
    Other Study ID Numbers:
    • FML - 204
    First Posted:
    Oct 9, 2013
    Last Update Posted:
    Oct 9, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Solitary Pulmonary Nodule

    Study Results

    No Results Posted as of Oct 9, 2013