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A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

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Trial Information

A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer

Inclusion Criteria


Inclusion Criteria

Subjects who meet all of the following criteria may be enrolled in this Study:

1. Subject is male or female, age 18 or older.

2. Subject has undergone CT scan of the lung(s) that indicates one or more non-calcified
nodules or lesions suspicious for lung cancer.

3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the
largest nodule or lesion dimension identified from CT imaging.

4. Subject is indicated for a tissue biopsy of the lung.

5. Subject must be able to receive a ProLung Test within 60 days of abnormal CT
(Inclusion Criterion 2 & 3) or within 60 days prior to the tissue biopsy (Inclusion
Criterion 4).

6. Subject is capable of understanding and agreeing to fulfill the requirements of this
Protocol.

7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

Exclusion Criteria

The following criteria will disqualify a subject from enrollment into this Study:

1. Subject has an implanted electronic device in the chest.

2. Subject receiving therapy for suspected chest infection such as fungal infection or
tuberculosis.

3. Subject with diagnosed malignancy within the past 5 (five) years except for
non-melanoma skin cancer and lung cancer.

4. Subject has received systemic corticosteroid medication within 14 days prior to
ProLung Test (except for ophthalmic preparations or inhaled medications used more
than 4 hours prior to ProLung Test).

5. Subject has received an invasive medical or surgical procedure within the thoracic
cavity within 30 days prior to the ProLung Test or within the previous 14 days for a
bronchoscopic procedure.

6. Subject presents with an anomalous physical or anatomical condition that precludes
ProLung Test measurement.

7. Subject will have undergone unusually strenuous exercise within 24 hours.

8. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced
heart failure, or a recent myocardial infarction, or other medical condition such as
severe morbid obesity that in the judgment of the Principal Investigator would make
him/her unsuitable for the Study.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Clinical Efficacy in the risk stratification of patients with indeterminate lesions

Outcome Description:

Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicous for lung cancer.

Outcome Time Frame:

The ProLung Test will be performed on patients prior to their indicated biopsy and evaluated against conclusive post biopsy pathology results

Safety Issue:

Yes

Principal Investigator

Rex C Yung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Medical Center

Authority:

United States: Institutional Review Board

Study ID:

PL-208

NCT ID:

NCT01566682

Start Date:

October 2012

Completion Date:

April 2013

Related Keywords:

  • Solitary Pulmonary Nodule
  • Multiple Pulmonary Nodules
  • Lung Lesion
  • Lung Mass
  • Lung Nodule
  • Lung Cancer
  • Low-Dose CT
  • CT
  • Diagnostic
  • Evaluation
  • Bioconductance
  • ProLung
  • Lung Neoplasms
  • Multiple Pulmonary Nodules
  • Solitary Pulmonary Nodule

Name

Location

Huntsman Cancer Institute Salt Lake City, Utah  84112
UCLA Los Angeles, California  90095
Henry Ford Medical Center Dearborn, Michigan  48126