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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05530408
Other study ID # STUDY00148295
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 24, 2022
Est. completion date May 31, 2028

Study information

Verified date May 2024
Source University of Kansas Medical Center
Contact Cristal Monge
Phone 9135882473
Email chernandez@kumc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Biospecimen Collection Correlate imaging biomarkers with biospecimens and physiological/vital signs data. From Enrollment to 6 Months
Primary 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
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