Fast Ultra Low Dose CT Interpretation

Thoracic Clinical Trial

Official title:

Fast Ultra Low Dose CT Interpretation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05748184
• Other study ID #: ICBE-S-000604
• Status: Terminated
• Start date: February 7, 2023
• Est. completion date: August 24, 2023

Study information

• Verified date: August 2023
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An ultra-low-dose CT(ULDCT) image viewer prototype was developed in an iterative fashion that aims to reduce average interpretation times of ULDCT images. Ultimately, by reducing reading time of ULDCTs, we aim to enable general replacement of X-ray by ULDCT imaging, which is theorized to have large population-level health outcome impact in terms of early detection of lung cancer, coronary calcification, and aortic aneurysm, among others.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 24, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents employed by LUMC who read CTs and x-rays as part of clinical workflow.
• Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents who have been employed by LUMC who have read CT's and x-rays as part of clinical workflow.
• Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents who are visiting LUMC and who read CT's and x-rays as part of clinical workflow.
• Willing and able to provide informed consent.
• Interested and able to participate in at least two study arms, even if those have not yet been scheduled.
• Proficient in Dutch and/or English.

Exclusion Criteria:

• Prior exposure to elements of the advanced reading environment, i.e., prior to the first research arm.
• Not willing and able to provide informed consent. Contacts and Locations

Related Conditions & MeSH terms

• Thoracic

Intervention

Device:
• ULDCT PACS prototype
The ULDCT viewer prototype is a non-medical unreleased device that will be used by study participants on de-identified image cases in a research setting. The Prototype integrates new tools to speed up the diagnostic interpretation process of radiological images.
• PACS viewer prototype
A PACS system mimicking the clinical PACS system used in LUMC.
• Optimized ULDCT viewer prototype version(s)
The ULDCT viewer prototype is a non-medical unreleased device that will be used by study participants on de-identified image cases in a research setting. The Prototype integrates new tools to speed up the diagnostic interpretation process of radiological images. Optimized version(s) of previous version.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center (LUMC)	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologist interpretation time	Average radiologist interpretation time (seconds / minutes) of all cases in the two applications. This Outcome Measure is measured through activity log of the prototype.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Secondary	Confidence	Average radiologist confidence of all cases in the two applications. This Outcome Measure is measured through a questionnaire with responses on Likert scale.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Secondary	Usability and user experience	Radiologist perceived usability feedback per prototype application through System usability scale (SUS), observed user errors per reading session (%), and open-ended feedback from a semi-structured interview summarized qualitatively.; SUS scores are compared between prototype applications and influence of learning/time on the SUS is analyzed.; Region of interaction. Frequency and duration eye tracking.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Secondary	Emotional state	Average radiologist emotional state per case and per prototype application via video captures and gaze tracking. Emotional state is compared between prototype applications.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Secondary	Arousal state	Average radiologist arousal state per case and per prototype application via wrist-based biometrics (heart rate variability in miliseconds, heart rate in beats per minute (bpm), skin conductance in uS), and eye tracking pupil diameter in milimeters.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Secondary	Wrist band based biometrics	Average radiologists' heart rate, heart rate variability and skin conductance compared between cases read per prototype applications.	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.