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

NCT ID: NCT07092553

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with SOC image-guided intervention

Patients undergoing a standard of care (SOC) image-guided intervention of the head or body

C-arm PCD-CBCT

Intervention Type DEVICE

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

Interventions

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C-arm PCD-CBCT

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guang-Hong Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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UW Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Radiology Studies

Role: CONTACT

608-282-8349

Other Identifiers

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1R01EB034011-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534800

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MED PHYSICS/MED PHYSIC

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/10/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0677

Identifier Type: -

Identifier Source: org_study_id

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