CClinicalTrials.gg
Status unknownNCT05770024Updated Mar 25, 2024

Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging

An observational study in Subjects Undergoing Diagnostic Imaging Tests, sponsored by IRCCS SYNLAB SDN. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by IRCCS SYNLAB SDN · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Sex
All
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Study summary

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

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Conditions studied

  • Subjects Undergoing Diagnostic Imaging Tests
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In context

Lead sponsor

IRCCS SYNLAB SDN is the lead sponsor of 12 studies on the registry; 7 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects undergoing diagnostic imaging tests

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

Exclusion Criteria:

  • Incompleteness of data for the purpose of the review process
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • Otherimaging tests

    X-ray radiography (RX); computer tomography (CT); magnetic resonance (MR); positron emission tomography (PET); single photon emission computed tomography (SPECT)

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What researchers measure

Primary outcomes

  1. 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

    * Definition of a survey for evaluation of diagnostic procedures; * Definition of a panel of experts; * Optimization of radiological quality control workflow; * Identification of elements for workflow automation; * Definition of feedback strategies for the improvement of procedures diagnostics

    Time frame: 1-36 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, 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
NCT05770024
Lead sponsor
IRCCS SYNLAB SDN
Responsible party
Sponsor
First posted
Mar 15, 2023
Start date
Sep 3, 2020
Primary completion
Jan 31, 2024
Completion
Sep 30, 2024 (estimated)
Last update
Mar 25, 2024

Oversight

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

Not currently enrolling

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

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