Clinical trial NCT05748184: Fast Ultra Low Dose CT Interpretation
Official title: Fast Ultra Low Dose CT Interpretation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ultra-low-dose CT
Thoracic
Keywords: CT
Reading Ultra low dose CT
ULDCT
Radiologists
Radiology
Xray
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
Collaborators: name: Leiden University Medical Center
First posted: 2023-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiologist interpretation time
timeFrame: 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:
measure: Confidence
timeFrame: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
measure: Usability and user experience
timeFrame: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
measure: Emotional state
timeFrame: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
measure: Arousal state
timeFrame: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
measure: Wrist band based biometrics
timeFrame: Measured per reading session of about 4-5 hours (maximum 10 hours) and detailed out per CT reading case of about 3-20 minutes.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
Study officials:
affiliation: Leiden University Medical Center
name: Hildo Lamb, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: