Pulmonary DiseaseNCT03622528
Quantitative Lung Cancer Screening
An observational study of Pulmonary Disease and Chronic Obstructive Pulmonary Disease, run by Jessica Sieren.
Trial summary
The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Cancer, Lung
- What is being tested?
- Chest CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 74 years
- All sexes
- Adult, Older adult
Study population: Subjects will be patients at the University of Iowa Hospitals and Clinics that are participating in the Lung Cancer Screening clinic and have met those guidelines for being included in that screening program.
Who may be able to join
- Subjects that meet the clinical Lung Cancer Screening guidelines and participate in that clinical screening.
Who cannot join
- Subjects that do not meet the clinical Lung Cancer Screening guidelines.
About this study
Official title: Precision, Pulmonary Disease Evaluation and Lung Cancer Detection Using Quantitative Low-dose CT
The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.
Read the detailed description
The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.
The Lung Cancer Screening Clinic is a new program that screens a group of patients that meet a predetermined criteria, set by the program, for lung cancer. At this time primary care providers, within the UIowa network, have the ability to place an order for this screening process for their patients. The hope is to expand this program to any primary care provider in the future. Clinic staff look over the patients past medical history to determine if they fit the clinic criteria.
For this study, the study team will ask the patients seen in the lung cancer screening clinic at the University of Iowa to undergo an additional standard dose CT scan during that same visit(for comparison/validation of the software performance). For those subjects that agree to participate, the study team will also ask to collect the data and CT scans that were also collected for their clinical Lung Cancer Screening visit. For this group the study team will also ask to collect all medical records associated with nodules found at this Lung Cancer Screening visit.
The study team propose to test the performance of VIDA's existing image analysis tools for the assessment of chronic obstructive pulmonary disease (COPD), when applied to the LDCT data acquired for lung cancer screening. The study team will also develop new lung nodule evaluation functions to specifically address the clinical needs within the at-risk lung cancer patient population.
To carry out the work, the study team propose two specific aims:
- Validate VIDA's quantitative computed tomography (QCT) metrics for COPD and emphysema utilizing the lung cancer LDCT screening cohort as compared to the standard quantitative high resolution computed tomography (HRCT) scanning protocol. With collaboration between the University of Iowa and VIDA, the study team will establish a tightly controlled, CT data acquisition protocol in our local lung cancer screening program. Data collected will incorporate thin-slice and iterative reconstructions, breath coaching to target lung inflation levels for patients and HRCT data acquisition in a sub-cohort. The VIDA analysis will be refined and the appropriate reconstruction setting identified such that the outputs from the LDCT data correlate to the HRCT (current standard) outputs.
- Complete and refine development of VIDA's novel lung nodule segmentation algorithm for solid and non-solid nodules using the standardized lung cancer LDCT screening protocol. Automated nodule segmentation in CT scans is challenging due to border ambiguity with neighboring structures (such as vessels and the pleura), poor boundary contrast of more subtle nodules, and noise associated with LDCT. The study team will develop a novel method that robustly segments pulmonary lesions by allowing mutual interaction between the nodules and surrounding structures, leading to a highly accurate segmentation with less manual corrective actions for a high volume lung cancer screening workflow.
- Being tested
- Chest CT scan
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT scanRadiation
Standard dose chest CT scan
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Screening Cohort | Patients who are seen in the UIHC lung cancer screening clinic will be asked to undergo an additional standard chest CT scan during their UIHC clinical lung cancer screening CT scan. Additionally, data from that clinical scan and all medical records associated with nodules that were discovered by the Lung Cancer Screening, will also be collected. Receives: Radiation: Chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Airway Branch Differences
Segmental airway branch differences will be measured by comparing the clinical low dose chest CT scan and the standard dose chest CT scan.
Measured: 1 day of Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Funding Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Sieren
- Sponsor type
- University, hospital or other
- Collaborators
- Vida Diagnostics, Inc
- Responsible party
- Sponsor-investigator, Jessica Sieren, University of Iowa
- Investigators
- Jessica Sieren, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622528
- Sponsor's protocol ID
- 201603824
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2018
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision, Pulmonary Disease Evaluation and Lung Cancer Detection Using Quantitative Low-dose CT
- ClinicalTrials.gov ID
- NCT03622528
- Acronym / sponsor ID
- 201603824
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jessica SierenUniversity, hospital or other
- Collaborators
- Vida Diagnostics, Inc
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.
Detailed description
The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.
The Lung Cancer Screening Clinic is a new program that screens a group of patients that meet a predetermined criteria, set by the program, for lung cancer. At this time primary care providers, within the UIowa network, have the ability to place an order for this screening process for their patients. The hope is to expand this program to any primary care provider in the future. Clinic staff look over the patients past medical history to determine if they fit the clinic criteria.
For this study, the study team will ask the patients seen in the lung cancer screening clinic at the University of Iowa to undergo an additional standard dose CT scan during that same visit(for comparison/validation of the software performance). For those subjects that agree to participate, the study team will also ask to collect the data and CT scans that were also collected for their clinical Lung Cancer Screening visit. For this group the study team will also ask to collect all medical records associated with nodules found at this Lung Cancer Screening visit.
The study team propose to test the performance of VIDA's existing image analysis tools for the assessment of chronic obstructive pulmonary disease (COPD), when applied to the LDCT data acquired for lung cancer screening. The study team will also develop new lung nodule evaluation functions to specifically address the clinical needs within the at-risk lung cancer patient population.
To carry out the work, the study team propose two specific aims:
- Validate VIDA's quantitative computed tomography (QCT) metrics for COPD and emphysema utilizing the lung cancer LDCT screening cohort as compared to the standard quantitative high resolution computed tomography (HRCT) scanning protocol. With collaboration between the University of Iowa and VIDA, the study team will establish a tightly controlled, CT data acquisition protocol in our local lung cancer screening program. Data collected will incorporate thin-slice and iterative reconstructions, breath coaching to target lung inflation levels for patients and HRCT data acquisition in a sub-cohort. The VIDA analysis will be refined and the appropriate reconstruction setting identified such that the outputs from the LDCT data correlate to the HRCT (current standard) outputs.
- Complete and refine development of VIDA's novel lung nodule segmentation algorithm for solid and non-solid nodules using the standardized lung cancer LDCT screening protocol. Automated nodule segmentation in CT scans is challenging due to border ambiguity with neighboring structures (such as vessels and the pleura), poor boundary contrast of more subtle nodules, and noise associated with LDCT. The study team will develop a novel method that robustly segments pulmonary lesions by allowing mutual interaction between the nodules and surrounding structures, leading to a highly accurate segmentation with less manual corrective actions for a high volume lung cancer screening workflow.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Screening Cohort | – | Radiation: Chest CT scanPatients who are seen in the UIHC lung cancer screening clinic will be asked to undergo an additional standard chest CT scan during their UIHC clinical lung cancer screening CT scan. Additionally, data from that clinical scan and all medical records associated with nodules that were discovered by the Lung Cancer Screening, will also be collected. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects will be patients at the University of Iowa Hospitals and Clinics that are participating in the Lung Cancer Screening clinic and have met those guidelines for being included in that screening program.
Key inclusion criteria (1 listed)
- Subjects that meet the clinical Lung Cancer Screening guidelines and participate in that clinical screening.
Key exclusion criteria (1 listed)
- Subjects that do not meet the clinical Lung Cancer Screening guidelines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT scanStandard dose chest CT scan | Radiation | Lung Cancer Screening Cohort |
Primary outcome
Segmental Airway Branch Differences
Time frame: 1 day of Study Visit
Segmental airway branch differences will be measured by comparing the clinical low dose chest CT scan and the standard dose chest CT scan.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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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.
Jessica Sieren, PhD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Chronic Obstructive Pulmonary Disease, run by Jessica Sieren.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Segmental Airway Branch Differences (time frame: 1 day of Study Visit). 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 27 Nov 2024.