Fast Ultra Low Dose CT Interpretation

August 25, 2023 updated by: Philips Electronics Nederland B.V. acting through Philips CTO organization
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center (LUMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects are not patients, but diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents employed, formally employed by LUMC or visiting LUMC who read CTs and x-rays as part of clinical workflow.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiologists
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.
Device: PACS viewer prototype
A PACS system mimicking the clinical PACS system used in LUMC.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologist interpretation time
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Collaborators

Leiden University Medical Center

Investigators

  • Principal Investigator: Hildo Lamb, Prof. Dr., Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Actual)

April 13, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICBE-S-000604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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