Ultra-low-dose CTNCT05748184
Fast Ultra Low Dose CT Interpretation
An observational study of Ultra-low-dose CT and Thoracic, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultra-low-dose CT, Thoracic
- What is being tested?
- ULDCT PACS prototype, PACS viewer prototype and Optimized ULDCT viewer prototype version(s)
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2023to 24 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ultra-low-dose CT, Thoracic
- Being tested
- ULDCT PACS prototype, PACS viewer prototype, Optimized ULDCT viewer prototype version(s)
- Keywords
- CT, Reading Ultra low dose CT, ULDCT, Radiologists, Radiology, Xray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULDCT PACS prototypeDevice
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.
PACS viewer prototypeDevice
A PACS system mimicking the clinical PACS system used in LUMC.
Optimized ULDCT viewer prototype version(s)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiologists | Not described Receives: Device: ULDCT PACS prototype; Device: PACS viewer prototype; Device: Optimized ULDCT viewer prototype version(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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 (5)
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: 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: 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: 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: 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: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start7 Feb 2023
- Primary completion13 Apr 2023
- Study completion24 Aug 2023
Why it stopped: Due to company reorganization and business interests.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-low-dose CTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Hildo Lamb, Prof. Dr., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748184
- Sponsor's protocol ID
- ICBE-S-000604
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Ultra Low Dose CT Interpretation
- ClinicalTrials.gov ID
- NCT05748184
- Acronym / sponsor ID
- ICBE-S-000604
- Conditions
- Ultra-low-dose CT, Thoracic
- Keywords
- CT, Reading Ultra low dose CT, ULDCT, Radiologists, Radiology, Xray
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to company reorganization and business interests.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiologists | – | Device: ULDCT PACS prototype, Device: PACS viewer prototype, Device: Optimized ULDCT viewer prototype version(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULDCT PACS prototypeThe 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 | Radiologists |
| PACS viewer prototypeA PACS system mimicking the clinical PACS system used in LUMC. | Device | Radiologists |
| 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. | Device | Radiologists |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Due to company reorganization and business interests.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hildo Lamb, Prof. Dr. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultra-low-dose CT and Thoracic, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to company reorganization and business interests.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.