Solitary Pulmonary NoduleNCT01566682
A Multi-Center Trial of the ProLung Test™
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Fresh Medical Laboratories at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
- How many people
- 420 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2012to Mar 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with pulmonary lesions suspicious for lung cancer
Who may be able to join
- Subjects who meet all of the following criteria may be enrolled in this Study:
- Subject is male or female, age 18 or older.
- Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.
- Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
- Subject meets one or more of the following conditions:
- indicated for a tissue biopsy
Show all 12Show fewer
- indicated for surgical resection of the lung
- 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).
- Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
- Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
Who cannot join
- The following criteria will disqualify a subject from enrollment into this Study:
- Subject has an implanted electronic device in the chest.
- Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
- 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.
- 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.
- Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
- Subject will have undergone unusually strenuous exercise within 24 hours.
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425-6300
Henry Ford Medical Center
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90024
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55454
Intermountain Healthcare
Murray, Utah, 84157
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
UCSD Medical Center
San Diego, California, 92103
Stanford University Medical Center
Stanford, California, 94305
Greater Baltimore Medical Center
Towson, Maryland, 21204
Providence Health Center
Waco, Texas, 76712
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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
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:
Read more
- Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
- Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
- 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.
- Keywords
- Lung Lesion, Lung Mass, Lung Nodule, Lung Cancer, Low-Dose CT, CT, Diagnostic, Evaluation, Bioconductance, ProLung
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate Pulmonary Lesions | Patients with Pulmonary Lesions as seen by CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions
Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresh Medical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 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, Masonic Cancer Center, University of Minnesota, Beth Israel Deaconess Medical Center, Medical University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566682
- Sponsor's protocol ID
- PL-208
- Status last verified
- Aug 2019
- First submitted
- 27 Mar 2012
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01566682
- Acronym / sponsor ID
- PL-208
- Keywords
- Lung Lesion, Lung Mass, Lung Nodule, Lung Cancer, Low-Dose CT, CT, Diagnostic, Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Fresh Medical LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- 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, Masonic Cancer Center, University of Minnesota, Beth Israel Deaconess Medical Center, Medical University of South Carolina
- Study start
- Oct 2012
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
- Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indeterminate Pulmonary Lesions | – | –Patients with Pulmonary Lesions as seen by CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary lesions suspicious for lung cancer
Key inclusion criteria (12 listed)
- Subject is male or female, age 18 or older.
- Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.
- Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
- Subject meets one or more of the following conditions:
- Subject must be able to receive a ProLung Test
Key exclusion criteria (8 listed)
- Subject has an implanted electronic device in the chest.
- Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
- 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.
- 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.
- Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions
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.
Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Fresh Medical Laboratories at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.