- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770024
Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging
March 22, 2024 updated by: IRCCS SYNLAB SDN
The purpose of the study is to validate a radiological quality control (QC) system on the performance of diagnostic imaging.
Patient images, previously anonymized by each radiologic diagnostic structures (SDR), will be sent to the QC service, which will blindly submit the images for evaluation external peer review by experts in the field.
Through the blinded approach, the information obtained from the QC will allow the SDR to know its own performance analytics, but not those of other SDRs using the service, and to a centralized system to have an anonymized estimate of the quality of performance delivered.
Finally, the analyzed data will provide not only a mere count, but will allow to reduce and prevent errors in the appropriateness, execution, reporting and diagnostic content of the examinations
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Naples, Italy, 80143
- Recruiting
- Irccs Synlab Sdn
-
Contact:
- Laura Pierri, MSC
- Phone Number: 0812408470
- Email: direzionescientifica.irccssdn@synlab.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects undergoing diagnostic imaging tests
Description
Inclusion Criteria:
- Diagnostic examinations related to imaging modalities (RX, CT, MR, PET, SPECT...), agreed with SDRs, of body districts on which diagnostic images are available in DICOM format, medical history data and clinical question, report
Exclusion Criteria:
- Incompleteness of data for the purpose of the review process
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Definition and implementation of diagnostic image quality control procedures for the purpose of purposes of monitoring the accuracy and appropriateness of the service provided by SDRs
Time Frame: 1-36 months
|
|
1-36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2020
Primary Completion (Actual)
January 31, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
March 3, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 10/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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