CT ScanPhase 2NCT07192133
Evaluation of CT-XPI
A Phase 2 study testing CT scan in people with CT Scan and Computed Tomography, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CT Scan, Computed Tomography
- What is being tested?
- CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Matthew Smith, MD, PhD
Timothy Szczykutowicz, PhD
About this study
Official title: Evaluation of Computed Tomography X-ray-Pulsatility Index (CT-XPI)
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.
Read the detailed description
The purpose of the study is to evaluate X-ray Pulsatility Index using prospectively acquired dynamic CT, which is different from conventional static CT scans.
The primary objective of this study is to collect dynamic CT scan data with human participants using high frame rate imaging methods to produce a map of lung perfusion.
- Conditions
- CT Scan, Computed Tomography
- Being tested
- CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Dynamic contrast-free chest CT scan
| Study group | Role | What they receive |
|---|---|---|
| CT scan | Experimental | Participants undergoing a CT Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Magnitude of XPI
Measured as a number, this corresponds to the magnitude of the relative change of signal.
Measured: 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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start26 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT ScanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Smith, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192133
- Sponsor's protocol ID
- 2025-0586
- Other IDs
- SMPH/RADIOLOGY/RADIOLOGY, AS, Protocol Version 1/18/2025
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computed Tomography X-ray-Pulsatility Index (CT-XPI)
- ClinicalTrials.gov ID
- NCT07192133
- Acronym / sponsor ID
- 2025-0586
- Conditions
- CT Scan, Computed Tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to evaluate X-ray Pulsatility Index using prospectively acquired dynamic CT, which is different from conventional static CT scans.
The primary objective of this study is to collect dynamic CT scan data with human participants using high frame rate imaging methods to produce a map of lung perfusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan | Experimental | Diagnostic Test: CT scanParticipants undergoing a CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanDynamic contrast-free chest CT scan | Diagnostic test | CT scan |
Primary outcome
Lung x-ray pulsatility index (XPI)
Time frame: 30 minutes
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.
Magnitude of XPI
Time frame: 30 minutes
Measured as a number, this corresponds to the magnitude of the relative change of signal.
Presence of XPI
Time frame: 30 minutes
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.
Spatial distribution of XPI signal
Time frame: 30 minutes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Smith, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT scan in people with CT Scan and Computed Tomography, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Studies (608-282-8349, radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung x-ray pulsatility index (XPI) (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.