NCT05530408

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2022May 2028

Study Start

First participant enrolled

May 24, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5.6 years

First QC Date

September 2, 2022

Last Update Submit

April 30, 2026

Conditions

Keywords

XenonXe-129CT

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating in an Imaging Study at KUMC

You may qualify if:

  • 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.

You may not qualify if:

  • The participant declines to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Peter J Niedbalski, PhD

    Research Assistant Professor

    PRINCIPAL INVESTIGATOR
  • Luigi R Boccardi, MPH

    Director of Pulmonary, Critical Care, & Sleep Research

    STUDY DIRECTOR

Central Study Contacts

Cristal Monge

CONTACT

Adam M Ruff, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

May 24, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Access Criteria
Contact Peter J. Niedbalski, PhD to discuss accessing IPD.

Locations