Photon Counting Detector CT Image Quality

Diagnostic Imaging Clinical Trial

Official title:

Image Quality and Diagnostic Accuracy of Photon Counting Computed Tomography of the Upper and Lower Extremity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281808
• Other study ID #: R490
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Balgrist University Hospital
• Contact: Reto Sutter, MD
• Phone: 0041443861111
• Email: reto.sutter[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Computed tomography (CT) imaging plays a key role in diagnostic radiology, and is particularly valuable in assessing a myriad of musculoskeletal conditions (e.g. trauma, degenerative disorders, post-surgical follow-up, inflammatory diseases). The vast majority of today's CT scanners are equipped with an energy-integrating detector (EID), which converts energy of incoming X-ray photons in a two-step process into electric signals: First, scintillators generate visible light, which in turn is converted to the electric signal by photodiodes. Recently, photon-counting detector computed tomography (PCD-CT) scanners became commercially available and have been introduced to improve imaging performance through direct transformation of X-ray photons into electron hole pairs upon absorption in a semiconductor layer, generating an electrical signal proportional to the photon energy. Current literature has shown that PCD-CT can offer higher spatial resolution, increased contrast-to-noise ratio, higher dose-efficiency, and inherent multi-spectral imaging capacity. Moreover, the results from cadaver studies suggest that PCD-CT can preserve image quality with reduced radiation dose. However, data on the diagnostic accuracy of PCD-CT compared to EID-CT is currently limited in the field of musculoskeletal radiology. In addition to conventional CT acquisition, multi-spectral CT imaging in patients with gout and after trauma, is used in clinical routine to delineate materials with a specific absorption coefficient: in gout, urate crystals can be visualized, while after trauma, bone marrow edema can be detected. For EID-CT, different techniques for multi-spectral CT imaging are available (e.g. fast kV switching, dual source CT) which are widely used in clinical routine. Multi-spectral imaging is also inherently available for recently introduced PCD-CT. However, data on diagnostic accuracy of multi-spectral PCD-CT is currently lacking.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Reto Sutter, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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