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

NCT07092553 | Not Yet Recruiting FDA Device

• 5 other identifiers: 2025-06771R01EB034011-01A1A534800SMPH/MED PHYSICS/MED PHYSICProtocol Version 3/10/2025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 and safe interventional procedures for patients.

Conditions

Imaging

Keywords

image-guided intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  image analysis will proceed after participant data collection is complete (up to 2 years)

Study Arms (1)

Patients with SOC image-guided intervention

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

Device: C-arm PCD-CBCT

Interventions

C-arm PCD-CBCT DEVICE

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

Patients with SOC image-guided intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a SOC image-guided intervention of the head or body

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Guang-Hong Chen, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)