A Multi-Center Trial of the ProLung Test™

• Sponsor: Fresh Medical Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01566682
• Collaborator: Huntsman Cancer Institute (Other), University of California, Los Angeles (Other), Henry Ford Health System (Other), University of California, San Diego (Other), Intermountain Health Care, Inc. (Other), M.D. Anderson Cancer Center (Other), Greater Baltimore Medical Center (Other), Stanford University (Other), Loyola University (Other), Providence Health Center (Other), Wake Forest (Other), University of Minnesota Masonic Cancer Center (Other), Beth Israel Deaconess Medical Center (Other), Medical University of South Carolina (Other)
• Enrollment: 420
• Locations: 15
• Duration (Months): 76.9
• Patients Per Site: 28
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.

There are three Specific Aims of this study:

1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.

2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.

3. Assess the safety and tolerability of the ProLung Test procedures.

Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Study Design

• Study Type: Observational
• Actual Enrollment: 420 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Indeterminate Pulmonary Lesions Patients with Pulmonary Lesions as seen by CT

Outcome Measures

Primary Outcome Measures

1. Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions [The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.]

   Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious 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:

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 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 meets one or more of the following conditions:

• indicated for a tissue biopsy

• indicated for surgical resection of the lung

1. Subject must be able to receive a ProLung Test

• within 60 days of abnormal CT (Inclusion Criterion 2 & 3)

• within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4).

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

2. 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 other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules.

4. 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.

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

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

7. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90024
2	UCSD Medical Center	San Diego	California	United States	92103
3	Stanford University Medical Center	Stanford	California	United States	94305
4	Loyola University Medical Center	Maywood	Illinois	United States	60153
5	Greater Baltimore Medical Center	Towson	Maryland	United States	21204
6	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
7	Henry Ford Medical Center	Detroit	Michigan	United States	48202
8	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota	United States	55454
9	Mayo Clinic	Rochester	Minnesota	United States	55905
10	Wake Forest University	Winston-Salem	North Carolina	United States	27157
11	Medical University of South Carolina	Charleston	South Carolina	United States	29425-6300
12	MD Anderson Cancer Center	Houston	Texas	United States	77030
13	Providence Health Center	Waco	Texas	United States	76712
14	Intermountain Healthcare	Murray	Utah	United States	84157
15	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Fresh Medical Laboratories
• Huntsman Cancer Institute
• University of California, Los Angeles
• Henry Ford Health System
• University of California, San Diego
• Intermountain Health Care, Inc.
• M.D. Anderson Cancer Center
• Greater Baltimore Medical Center
• Stanford University
• Loyola University
• Providence Health Center
• Wake Forest
• University of Minnesota Masonic Cancer Center
• Beth Israel Deaconess Medical Center
• Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 18, 2016
• Statistical Analysis Plan - Jan 17, 2019

More Information

Publications

None provided.

• Responsible Party: Fresh Medical Laboratories
• ClinicalTrials.gov Identifier: NCT01566682
• Other Study ID Numbers: PL-208
• First Posted: Mar 29, 2012
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Fresh Medical Laboratories: Lung Lesion; Lung Mass; Lung Nodule; Lung Cancer; Low-Dose CT; CT; Diagnostic; Evaluation; Bioconductance; ProLung
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

Participant Flow

Arm/Group Title	Indeterminate Pulmonary Lesions
Arm/Group Description	Patients with Pulmonary Lesions as seen by CT
Period Title: Overall Study
STARTED	420
COMPLETED	374
NOT COMPLETED	46

Baseline Characteristics

Arm/Group Title	Indeterminate Pulmonary Lesions
Arm/Group Description	Patients with Pulmonary Lesions as seen by CT
Overall Participants	174
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	71 40.8%
>=65 years	103 59.2%
Sex: Female, Male (Count of Participants)
Female	92 52.9%
Male	82 47.1%
Race/Ethnicity, Customized (Count of Participants)
White	131 75.3%
Hispanic	15 8.6%
Indian	1 0.6%
East Indian	1 0.6%
Black	19 10.9%
Asian	6 3.4%
Unkown	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions
Description	Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
Time Frame	The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Outcome Measure Data

Analysis Population Description

Validation set of patients with indeterminate lung nodules

Arm/Group Title	Indeterminate Pulmonary Lesions
Arm/Group Description	Patients with Pulmonary Lesions as seen by CT
Measure Participants	174
Positive Predictive Value	70.37
Negative Predictive Value	46.97
Sensitvity	68.47
Specificity	49.21

Adverse Events

Time Frame	Adverse events were collected and reported on the day of measurement by the Study Device
Arm/Group Title	Indeterminate Pulmonary Lesions
Arm/Group Description	Patients with Pulmonary Lesions as seen by CT
All Cause Mortality
	Indeterminate Pulmonary Lesions
	Affected / at Risk (%)	# Events
Total	0/420 (0%)
Serious Adverse Events
	Indeterminate Pulmonary Lesions
	Affected / at Risk (%)	# Events
Total	0/420 (0%)
Other (Not Including Serious) Adverse Events
	Indeterminate Pulmonary Lesions
	Affected / at Risk (%)	# Events
Total	3/420 (0.7%)
Product Issues
Discomfort at Device Measurement Location	3/420 (0.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.