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Not yet recruiting NCT07092553

Evaluation of C-arm PCD-CBCT for Image-Guided Interventions

Observational Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-arm PCD-CBCT.
Who it may be relevant to
Registry conditions: Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Mean Confidence Score for Calcifications [Time frame: after participant data collection is complete (up to 1 year)]
  • Mean Confidence Score for Metal Artifacts [Time frame: after participant data collection is complete (up to 1 year)]
  • Area Under the Curve (AUC) for Calcification Detection [Time frame: image analysis will proceed after participant data collection is complete (up to 2 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UW Hospital and Clinics — Madison

Identifiers

NCT: NCT07092553 · 2025-0677 · 1R01EB034011-01A1 · A534800 · SMPH/MED PHYSICS/MED PHYSIC · Protocol Version 3/10/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗