Clinical trial NCT05530408: Quantitative Pulmonary Imaging Registry & Biorepository
Official title: Quantitative Pulmonary Imaging Registry & Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease
Keywords: Xenon
Xe-129
CT
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating in an Imaging Study at KUMC

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Collect Clinical Data
timeFrame: From Enrollment to 3 Months
measure: Establish a Biorepository
timeFrame: From Enrollment to 3 Months
measure: Biospecimen Collection
timeFrame: From Enrollment to 6 Months
measure: Collaborate
timeFrame: From Enrollment to 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Research Assistant Professor
name: Peter J Niedbalski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Pulmonary, Critical Care, & Sleep Research
name: Luigi R Boccardi, MPH
role: STUDY_DIRECTOR
References: