Fast Ultra Low Dose CT Interpretation

Study Overview
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Brief Summary
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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.

Official Title
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Fast Ultra Low Dose CT Interpretation

Conditions
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Ultra-low-dose CT, Thoracic

Intervention / Treatment
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* Device: ULDCT PACS prototype
* Device: PACS viewer prototype
* Device: Optimized ULDCT viewer prototype version(s)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiologists<br> | Device: ULDCT PACS prototype<br>* 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.<br>Device: PACS viewer prototype<br>* A PACS system mimicking the clinical PACS system used in LUMC.<br>Device: Optimized ULDCT viewer prototype version(s)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, Reading Ultra low dose CT, ULDCT, Radiologists, Radiology, Xray