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

NCT01958931 | Completed DMC

• 1 other identifier: FML - 204
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and Tolerability of the ProLung Test

  within 30 minutes of the ProLung Test

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fresh Medical Laboratories: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2011
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

US (1)