Fast Ultra Low Dose CT Interpretation

Terminated

• Conditions: Ultra-low-dose CT; Thoracic
• Interventions: Device: ULDCT PACS prototype; Device: PACS viewer prototype; Device: Optimized ULDCT viewer prototype version(s)

• Registration Number: NCT05748184
• Lead Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study Start: 2023-02-07
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Primary Completion: 2023-04-13
• Status Verified: 2023-08
• Study Completion: 2023-08-24
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiologists	PACS viewer prototype	-
Radiologists	ULDCT PACS prototype	-
Radiologists	Optimized ULDCT viewer prototype version(s)	-

Primary Outcome Measures

Name	Time	Method
Radiologist interpretation time	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	Average radiologist interpretation time (seconds / minutes) of all cases in the two applications. This Outcome Measure is measured through activity log of the prototype.

Secondary Outcome Measures

Name	Time	Method
Emotional state	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	Average radiologist emotional state per case and per prototype application via video captures and gaze tracking. Emotional state is compared between prototype applications.
Arousal state	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	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.
Wrist band based biometrics	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	Average radiologists' heart rate, heart rate variability and skin conductance compared between cases read per prototype applications.
Confidence	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	Average radiologist confidence of all cases in the two applications. This Outcome Measure is measured through a questionnaire with responses on Likert scale.
Usability and user experience	Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.	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.

Trial Locations

Locations (1)

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands