Skip to content

Replacing Conventional Chest X-Ray Imaging with Ultra-low-dose CT: The REPLAiCE Study

Replacing Conventional Chest X-Ray Imaging with Ultra-low-dose CT: The REPLAiCE Study - REPLAiCE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57304
Enrollment
3400
Registered
2025-02-11
Start date
2025-04-08
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aandoeningen die als nevenbevinding tijdens radiologisch thoraxonderzoek worden gevonden diseases which concern the lungs Pulmonary diseases

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: The primary inclusion criterion is patients >= 18 years presenting in the hospital for conventional chest X-Ray imaging for suspected non-traumatic pulmonary disease. This includes but is not limited to coughing, dyspnea, fever, chest pain or a work-up requested by another physician.

Exclusion criteria

Exclusion criteria: The following are exclusion criteria: - Patients who are not able to undergo either a chest X-Ray or a chest ULDCT - Pregnant patients - Patients who cannot move without aid. - Patients already participating in this RCT. - Patients with anticipated barriers to complete follow-up data collection. - Patients who don*t sign informed consent for participation in this study.

Design outcomes

Primary

MeasureTime frame
The primary clinical outcome measure is functional health at one year, evaluated using the physical summary component of the SF-12 questionnaire. This standardized and widely applicable instrument has been chosen to assess health-related quality of life from both the patient*s perspective and their engagement with the healthcare system, ensuring applicability across a broad spectrum of diseases.

Secondary

MeasureTime frame
Secondary outcomes are measures are • Quantity and type of follow-up imaging, assessed using the electronic patient records • Mental health, which is assessed by the mental health summary scale of the SF-12 • Length of hospital stay, expressed in days and extracted from electronic patient records • Mortality within one year, extracted from electronic patient records • Percentage of normal (i.e., absence of disease) compared to abnormal scan reports, extracted from electronic patient records • Time to diagnosis (where applicable), defined as the time between presentation in the hospital and a definitive diagnostic formulated by the referring physician • Time to treatment (where applicable), defined as the time between presentation and the start of a treatment • Number of patients in follow-up due to incidental findings, extracted from electronic patient records • Patient satisfaction and experience with participation, as assessed through the Generic Short Patient Experiences Questionnaire • Referring physician experience, assessed through questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)