Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07092553

Evaluation of C-arm 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unable to provide informed consent on their own behalf due to cognitive impairment
  • Pregnant or breastfeeding

Treatment and study plan

C-arm PCD-CBCT

Device

A single research PCD-CBCT scan will be performed directly after the participant's SOC scan.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Radiology Studies

CONTACT

[email protected]

608-282-8349

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

Evaluation of C-arm Photon Counting Detector Cone Beam CT (PCD-CBCT) for Image-Guided Interventions

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.