ImagingNCT07092553
Evaluation of C-arm PCD-CBCT for Image-Guided Interventions
An observational study of Imaging, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overarching objective of the project is to develop a new C-arm interventional x-ray imaging platform that integrates both a photon counting detector and a flat panel detector to provide high image quality and quantitative spectral computed tomography (CT) image guidance will be developed to enable more accurate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging
- What is being tested?
- C-arm PCD-CBCT
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2028
- Phase
- Observational
- 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
Study population: Patients undergoing a SOC image-guided intervention of the head or body
Who may be able to join
- Not pregnant or breastfeeding
- Scheduled to receive image-guided intervention (IGI) of the head or the body
- Pre-treatment multidetector computed tomography (MDCT) images available
Who cannot join
- Unable to provide informed consent on their own behalf due to cognitive impairment
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of C-arm Photon Counting Detector Cone Beam CT (PCD-CBCT) for Image-Guided Interventions
The overarching objective of the project is to develop a new C-arm interventional x-ray imaging platform that integrates both a photon counting detector and a flat panel detector to provide high image quality and quantitative spectral computed tomography (CT) image guidance will be developed to enable more accurate and safe interventional procedures for patients.
Read the detailed description
The objective of this pilot study is to assess the feasibility of acquiring high-quality images using new imaging concepts and methods. All imaging will be performed in addition to standard-of-care procedures and will not influence clinical decisions or patient management.
The endpoint of this project includes: 1) PCD-CBCT data will be processed to generate virtual non-iodine images for evaluating contrast extravasation, as well as virtual monoenergetic (VME) images. 2) Images will be analyzed retrospectively to evaluate image quality and explore potential clinical benefits of PCD-CBCT compared to flat panel detector cone beam CT (FPD-CBCT) and multidetector computed tomography (MDCT).
- Conditions
- Imaging
- Being tested
- C-arm PCD-CBCT
- Keywords
- image-guided intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-arm PCD-CBCTDevice
A single research PCD-CBCT scan will be performed directly after the participant's SOC scan.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SOC image-guided intervention | Patients undergoing a standard of care (SOC) image-guided intervention of the head or body Receives: Device: C-arm PCD-CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Confidence Score for Calcifications
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify calcifications and extravasated iodine contrast (if available) and provide a 1 (low) to 5 (high) confidence score on each image.
Measured: after participant data collection is complete (up to 1 year)
Mean Confidence Score for Metal Artifacts
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify metal artifacts (if any) and provide a 1 (low) to 5 (high) confidence score on each image.
Measured: after participant data collection is complete (up to 1 year)
Area Under the Curve (AUC) for Calcification Detection
For all reading studies, the order of subjects and imaging modality (MDCT, FPD-CBCT, and PCD-CBCT) will be randomized; three separate reading sessions will be implemented with a washout period of at least 3 months between sessions.
For calcification and iodine staining detection in the human subjects, the receiver operating characteristic (ROC) curves will be calculated using the maximum-likelihood method with the binormal model. The 95% confidence interval (CI) of each ROC curve will be estimated and the area under the curve (AUC) and its 95% CI will be calculated.
Measured: image analysis will proceed after participant data collection is complete (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImagingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Guang-Hong Chen, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092553
- Sponsor's protocol ID
- 2025-0677
- Other IDs
- 1R01EB034011-01A1, A534800, SMPH/MED PHYSICS/MED PHYSIC, Protocol Version 3/10/2025
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C-arm Photon Counting Detector Cone Beam CT (PCD-CBCT) for Image-Guided Interventions
- ClinicalTrials.gov ID
- NCT07092553
- Acronym / sponsor ID
- 2025-0677
- Conditions
- Imaging
- Keywords
- image-guided intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jul 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 overarching objective of the project is to develop a new C-arm interventional x-ray imaging platform that integrates both a photon counting detector and a flat panel detector to provide high image quality and quantitative spectral computed tomography (CT) image guidance will be developed to enable more accurate and safe interventional procedures for patients.
Detailed description
The objective of this pilot study is to assess the feasibility of acquiring high-quality images using new imaging concepts and methods. All imaging will be performed in addition to standard-of-care procedures and will not influence clinical decisions or patient management.
The endpoint of this project includes: 1) PCD-CBCT data will be processed to generate virtual non-iodine images for evaluating contrast extravasation, as well as virtual monoenergetic (VME) images. 2) Images will be analyzed retrospectively to evaluate image quality and explore potential clinical benefits of PCD-CBCT compared to flat panel detector cone beam CT (FPD-CBCT) and multidetector computed tomography (MDCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SOC image-guided intervention | – | Device: C-arm PCD-CBCTPatients undergoing a standard of care (SOC) image-guided intervention of the head or body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a SOC image-guided intervention of the head or body
Key inclusion criteria (3 listed)
- Not pregnant or breastfeeding
- Scheduled to receive image-guided intervention (IGI) of the head or the body
- Pre-treatment multidetector computed tomography (MDCT) images available
Key exclusion criteria (2 listed)
- Unable to provide informed consent on their own behalf due to cognitive impairment
- Pregnant or breastfeeding
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 |
|---|---|---|
| C-arm PCD-CBCTA single research PCD-CBCT scan will be performed directly after the participant's SOC scan. | Device | Patients with SOC image-guided intervention |
Primary outcome
Mean Confidence Score for Calcifications
Time frame: after participant data collection is complete (up to 1 year)
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify calcifications and extravasated iodine contrast (if available) and provide a 1 (low) to 5 (high) confidence score on each image.
Mean Confidence Score for Metal Artifacts
Time frame: after participant data collection is complete (up to 1 year)
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify metal artifacts (if any) and provide a 1 (low) to 5 (high) confidence score on each image.
Area Under the Curve (AUC) for Calcification Detection
Time frame: image analysis will proceed after participant data collection is complete (up to 2 years)
For all reading studies, the order of subjects and imaging modality (MDCT, FPD-CBCT, and PCD-CBCT) will be randomized; three separate reading sessions will be implemented with a washout period of at least 3 months between sessions. For calcification and iodine staining detection in the human subjects, the receiver operating characteristic (ROC) curves will be calculated using the maximum-likelihood method with the binormal model. The 95% confidence interval (CI) of each ROC curve will be estimated and the area under the curve (AUC) and its 95% CI will be calculated.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Guang-Hong Chen, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Imaging, 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 2 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: opening soon, as of the sponsor's last update on 29 Sep 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.
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?
Mean Confidence Score for Calcifications (time frame: after participant data collection is complete (up to 1 year)). The study lists 3 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 29 Sep 2026.