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Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer | Clinical Trials | Clareo Health

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

NCT01958931•Fresh Medical Laboratories

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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.
+3 more criteria

Locations (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

November 1, 2008

Completion Date

January 1, 2011

Last Updated

October 9, 2013

Enrollment

ACTUAL participants

Conditions

Solitary Pulmonary NoduleMultiple Pulmonary Nodules

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

NCT02448225

Lung CarcinomaSolitary Pulmonary Nodule+1 more

View study

UNKNOWN

A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

NCT04192201

Multiple Pulmonary Nodules

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

Prediction Model for Multiple Pulmonary Nodules

Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer

Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT