Quantitative Pulmonary Imaging Registry & Biorepository (PIBR)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Cristal Monge; Phone Number: 9135882473; Email: chernandez@kumc.edu
• Study Contact Backup: Name: Adam M Ruff, BS; Phone Number: 9135743932; Email: aruff@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Adam M Ruff, BS; Phone Number: 9135743932; Email: aruff@kumc.edu
      • Contact: Cristal Monge; Phone Number: 913-588-2473; Email: chernandez@kumc.edu
      • Principal Investigator: Peter J Niedbalski, PhD
      • Sub-Investigator: Jiwoong Choi, PhD
      • Sub-Investigator: Chase M Hall, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participating in an Imaging Study at KUMC

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The participant declines to participate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect Clinical Data	Collect relevant medical history (including demographic information, diagnoses, medical tests, smoking history), for patients participating in pulmonary imaging research.	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.	From Enrollment to 3 Months
Biospecimen Collection	Correlate imaging biomarkers with biospecimens and physiological/vital signs data.	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.	From Enrollment to 12 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Peter J Niedbalski, PhD, Research Assistant Professor; Study Director: Luigi R Boccardi, MPH, Director of Pulmonary, Critical Care, & Sleep Research

Publications and helpful links

Helpful Links

• KUMC Research - Quantitative Pulmonary Imaging Core

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CT; Xenon; Xe-129
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: STUDY00148295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: Contact Peter J. Niedbalski, PhD to discuss accessing IPD.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No