Photon Counting Detector CT Image Quality

NCT06281808 | Active Not Recruiting DMC

• 1 other identifier: R490
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard.

Conditions

Diagnostic Imaging; Tomography, X Ray Computed

Outcome Measures

Primary Outcomes (2)

• Image Quality PCD CT

  Likert scale based - 5 point Likert scale (0 = worst, 5 = best) Visual gradings of PCD-CT image quality. Image quality will be assessed by teams of experienced musculoskeletal radiologists. Images from consistent sets of intra-subject PCD-CT and EID-CT data will be presented to derive the primary outcome data, in particular using visual analog scales (Likert-Scales). Inter-reader reliability will be assessed.

  2 years

• Diagnostic Accuracy PCD CT

  This will involve the calculation of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The EID-CT image interpretation of the attending radiologists, as documented in the written report, will serve as reference standard against which the performance of PCD-CT will be compared. In cases with inconclusive written reports and image findings of EID-CT, a review committee consisting of experienced radiologists (e.g., other attending radiologists, chief of radiology) will be convened, and consensus reading including clinical correlation by consulting with the treating physicians and specialists involved in the patient's care will be done. Diagnostic confidence will be additionally analyzed for PCD-CT scans on a Likert-Scale. Inter-reader reliability will be assessed.

  2 years

Study Arms (1)

Photon Counting Detector CT

EXPERIMENTAL

PCD CT

Device: Photon Counting Detector CT

Interventions

Photon Counting Detector CT DEVICE

Photon counting detector CT scan with dose arbitrarily reduced compared to EID CT scan (e.g., half the dose of EID CT)

Photon Counting Detector CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted for non-contrast enhanced CT scan of the upper or lower extremity at the radiology department of Balgrist University Hospital
• Signed general consent ("Information zur Weiterverwendung gesundheitsbezogener Daten und Proben zu Forschungszwecken")
• \>18 years of age
• Written consent to participate in this study

You may not qualify if:

• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Women: pregnancy
• Age below 18 years
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to consent and/or follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Enrolment of the PI, his/her family members, employees and other dependent persons
• Body mass above 200 kg.
• Body mass below 31 kg.

Sponsors & Collaborators

• Reto Sutter, MD: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Reto Sutter

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 28, 2024
• Study Start: January 28, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)