Evaluation of CT-XPI

NCT07192133 | Recruiting Phase 2 DMC FDA Device

• 4 other identifiers: 2025-0586SMPH/RADIOLOGY/RADIOLOGYASProtocol Version 1/18/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a new computed tomography (CT) lung perfusion imaging method is as effective as standard of care (SOC) CT imaging. The main question it aims to answer is:

• Does the new contrast-free method provide more information about lung perfusion than SOC? Participants will undergo a 30 minute chest CT.

Conditions

CT Scan; Computed Tomography

Outcome Measures

Primary Outcomes (4)

• Lung x-ray pulsatility index (XPI)

  XPI, a representative of lung perfusion, will be measured using CT images. The dynamic x-ray attenuation from each pixel is analyzed using spectral analysis.

  30 minutes

• Magnitude of XPI

  Measured as a number, this corresponds to the magnitude of the relative change of signal.

  30 minutes

• Presence of XPI

  This will be evaluated quantitatively using CNR (contrast to noise) measurements which uses a region of interest in the lungs and a region of interest outside of the lungs.

  30 minutes

• Spatial distribution of XPI signal

  This is a subjective evaluation, routinely done clinically with other modalities that measure lung perfusion. Researchers evaluate how homogenous (smooth) the signal is over the lungs and look for perfusion defects (areas with little or no XPI) which would indicate pathology.

  30 minutes

Study Arms (1)

CT scan

EXPERIMENTAL

Participants undergoing a CT

Diagnostic Test: CT scan

Interventions

CT scan DIAGNOSTIC_TEST

Dynamic contrast-free chest CT scan

CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to sign and date the informed consent form
• Will undergo a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities

You may not qualify if:

• Pregnant or lactating
• In need of urgent or emergent care
• Have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the participant

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Matthew Smith, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; radstudy@uwhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)