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

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

Study Overview

• Status: Completed
• Conditions: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with lung cancer symptoms and pulmonary lesions suspicious for lung cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresh Medical Laboratories

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: FML - 204