CClinicalTrials.gg
TerminatedNCT05748184Updated Aug 29, 2023

Fast Ultra Low Dose CT Interpretation

An observational study in Ultra-low-dose CT and Thoracic, sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization · Observational

Why this study was terminated
Due to company reorganization and business interests.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ultra-low-dose CT
  • Thoracic

Keywords

  • CT
  • Reading Ultra low dose CT
  • ULDCT
  • Radiologists
  • Radiology
  • Xray
03

In context

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • Radiologists

    Device: ULDCT PACS prototype · Device: PACS viewer prototype · Device: Optimized ULDCT viewer prototype version(s)

Interventions

  • DeviceULDCT 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.

  • DevicePACS viewer prototype

    A PACS system mimicking the clinical PACS system used in LUMC.

  • DeviceOptimized 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Confidence

    Average radiologist confidence of all cases in the two applications. This Outcome Measure is measured through a questionnaire with responses on Likert scale.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. Wrist band based biometrics

    Average radiologists' heart rate, heart rate variability and skin conductance compared between cases read per prototype applications.

    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.

07

Study locations

1 site
  • Leiden University Medical Center (LUMC)
    Leiden, 2333 ZA, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05748184
Lead sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Leiden University Medical Center
Responsible party
Sponsor
First posted
Feb 28, 2023
Start date
Feb 7, 2023
Primary completion
Apr 13, 2023
Completion
Aug 24, 2023
Last update
Aug 29, 2023

Study contacts

Hildo Lamb, Prof. Dr.
principal investigator · Leiden University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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