Pulmonary DiseasePIBRNCT05530408
Quantitative Pulmonary Imaging Registry & Biorepository
An observational study of Pulmonary Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this project is to establish a registry and biorepository of images and biological samples from subjects undergoing novel pulmonary imaging methods to be used for future research aimed toward identifying clinical applications of imaging methods and toward understanding the physiological significance of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 31 May 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participating in an Imaging Study at KUMC
Who may be able to join
- The participant is enrolling/has enrolled in a research study at the University of Kansas Medical Center that involves Pulmonary MRI and/or Pulmonary CT.
Who cannot join
- The participant declines to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cristal Monge, 913-588-2473, chernandez@kumc.edu
Adam M Ruff, BS, 9135743932, aruff@kumc.edu
About this study
The goal of this project is to establish a registry and biorepository of images and biological samples from subjects undergoing novel pulmonary imaging methods to be used for future research aimed toward identifying clinical applications of imaging methods and toward understanding the physiological significance of imaging biomarkers. This registry and biorepository will accelerate the development of these imaging techniques and may lead toward future clinical adoption of quantitative pulmonary imaging.
Read the detailed description
Imaging is increasingly used for the non-invasive assessment of pulmonary health. Alongside this increased usage, there is enhanced interest in quantitative imaging methods that provide robust, repeatable, and objective measures of lung structure and function. At the forefront of this effort is quantitative computed tomography (qCT). CT imaging is the gold standard for high-resolution imaging of pulmonary structure, and the underlying physics of CT imaging is highly amenable to quantitative analysis.
In addition to qCT, MRI is garnering increased interest as a modality for pulmonary imaging. Like CT, MRI is non-invasive, and it has the additional advantage of being ionizing radiation-free, making it more suitable for repeat imaging and for use in pediatric patients. Traditionally, MRI was not often used for lung imaging due to several difficulties regarding the acquisition of quality images in the lungs. However, recent advances to pulmonary MRI methods have enabled the acquisition of high-quality images of pulmonary structure and function. These advances include the use of ultra-short and zero echo time (UTE and ZTE, respectively) MRI methods, as well as the use of gaseous contrast agents such as hyperpolarized 129Xe.
Despite these advances in qCT and MRI methods, the clinical applications for these imaging techniques are often unclear. Moreover, as new techniques, many of the imaging biomarkers in use have been independently developed by multiple sites and thus require standardization. As such, there is an urgent need both to standardize imaging/analysis techniques and to determine optimal clinical applications for these novel quantitative imaging methods.
- Conditions
- Pulmonary Disease
- Keywords
- Xenon, Xe-129, CT
- Medical subject headings
- Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Clinical Data
Collect relevant medical history (including demographic information, diagnoses, medical tests, smoking history), for patients participating in pulmonary imaging research.
Measured: From Enrollment to 3 Months
Establish a Biorepository
Establish a collection of biospecimens from imaging subjects to foster an improved understanding of the physiological significance of imaging biomarkers.
Measured: From Enrollment to 3 Months
Biospecimen Collection
Correlate imaging biomarkers with biospecimens and physiological/vital signs data.
Measured: From Enrollment to 6 Months
Collaborate
Provide images and biospecimens to researchers working to develop analysis methods for pulmonary CT and MRI. Separate IRB approval, alongside appropriate data and/or materials transfer agreements will be needed for these studies.
Measured: From Enrollment to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start24 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter J. Niedbalski, PhD, University of Kansas Medical Center
- Investigators
- Peter J Niedbalski, PhD, Principal investigator, Research Assistant ProfessorLuigi R Boccardi, MPH, Study director, Director of Pulmonary, Critical Care, & Sleep Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530408
- Sponsor's protocol ID
- STUDY00148295
- Acronym
- PIBR
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collaborators at KUMC that are not on the study team may request access to identified or deidentified data/biospecimens from this project. Collaborators may include parties outside of KUMC, in which case only deidentified data will be shared. When potential collaborators request access to data and/or biospecimens, the following will be considered: research question and study design, timing of request, and amount of specimen needed. Corporate entities will not be allowed access to data or samples from the biobank.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Pulmonary Imaging Registry & Biorepository
- ClinicalTrials.gov ID
- NCT05530408
- Acronym / sponsor ID
- PIBR / STUDY00148295
- Conditions
- Pulmonary Disease
- Keywords
- Xenon, Xe-129, CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 7 Sep 2022 (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 goal of this project is to establish a registry and biorepository of images and biological samples from subjects undergoing novel pulmonary imaging methods to be used for future research aimed toward identifying clinical applications of imaging methods and toward understanding the physiological significance of imaging biomarkers. This registry and biorepository will accelerate the development of these imaging techniques and may lead toward future clinical adoption of quantitative pulmonary imaging.
Detailed description
Imaging is increasingly used for the non-invasive assessment of pulmonary health. Alongside this increased usage, there is enhanced interest in quantitative imaging methods that provide robust, repeatable, and objective measures of lung structure and function. At the forefront of this effort is quantitative computed tomography (qCT). CT imaging is the gold standard for high-resolution imaging of pulmonary structure, and the underlying physics of CT imaging is highly amenable to quantitative analysis.
In addition to qCT, MRI is garnering increased interest as a modality for pulmonary imaging. Like CT, MRI is non-invasive, and it has the additional advantage of being ionizing radiation-free, making it more suitable for repeat imaging and for use in pediatric patients. Traditionally, MRI was not often used for lung imaging due to several difficulties regarding the acquisition of quality images in the lungs. However, recent advances to pulmonary MRI methods have enabled the acquisition of high-quality images of pulmonary structure and function. These advances include the use of ultra-short and zero echo time (UTE and ZTE, respectively) MRI methods, as well as the use of gaseous contrast agents such as hyperpolarized 129Xe.
Despite these advances in qCT and MRI methods, the clinical applications for these imaging techniques are often unclear. Moreover, as new techniques, many of the imaging biomarkers in use have been independently developed by multiple sites and thus require standardization. As such, there is an urgent need both to standardize imaging/analysis techniques and to determine optimal clinical applications for these novel quantitative imaging methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participating in an Imaging Study at KUMC
Key inclusion criteria (1 listed)
- The participant is enrolling/has enrolled in a research study at the University of Kansas Medical Center that involves Pulmonary MRI and/or Pulmonary CT.
Key exclusion criteria (1 listed)
- The participant declines to participate.
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
Collect Clinical Data
Time frame: From Enrollment to 3 Months
Collect relevant medical history (including demographic information, diagnoses, medical tests, smoking history), for patients participating in pulmonary imaging research.
Establish a Biorepository
Time frame: From Enrollment to 3 Months
Establish a collection of biospecimens from imaging subjects to foster an improved understanding of the physiological significance of imaging biomarkers.
Biospecimen Collection
Time frame: From Enrollment to 6 Months
Correlate imaging biomarkers with biospecimens and physiological/vital signs data.
Collaborate
Time frame: From Enrollment to 12 Months
Provide images and biospecimens to researchers working to develop analysis methods for pulmonary CT and MRI. Separate IRB approval, alongside appropriate data and/or materials transfer agreements will be needed for these studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- KUMC Research - Quantitative Pulmonary Imaging CoreLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Collaborators at KUMC that are not on the study team may request access to identified or deidentified data/biospecimens from this project. Collaborators may include parties outside of KUMC, in which case only deidentified data will be shared. When potential collaborators request access to data and/or biospecimens, the following will be considered: research question and study design, timing of request, and amount of specimen needed. Corporate entities will not be allowed access to data or samples from the biobank.
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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.
Peter J Niedbalski, PhD principal investigator
Research Assistant Professor
Luigi R Boccardi, MPH study director
Director of Pulmonary, Critical Care, & Sleep Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by University of Kansas Medical Center at 1 site 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 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristal Monge (9135882473, chernandez@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Clinical Data (time frame: From Enrollment to 3 Months). The study lists 4 primary outcomes in all. 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 6 May 2026.