Fast Ultra Low Dose CT Interpretation

Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05748184
Collaborator
Leiden University Medical Center (Other)
10
1
18.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ULDCT PACS prototype
  • Device: PACS viewer prototype
  • Device: Optimized ULDCT viewer prototype version(s)

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Fast Ultra Low Dose CT Interpretation
Actual Study Start Date :
Feb 7, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leiden University Medical Center (LUMC) Leiden Netherlands 2333 ZA

Sponsors and Collaborators

  • Philips Electronics Nederland B.V. acting through Philips CTO organization
  • Leiden University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philips Electronics Nederland B.V. acting through Philips CTO organization
ClinicalTrials.gov Identifier:
NCT05748184
Other Study ID Numbers:
  • ICBE-S-000604
First Posted:
Feb 28, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Philips Electronics Nederland B.V. acting through Philips CTO organization

Study Results

No Results Posted as of Mar 6, 2023