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

• Sponsor: IRCCS SYNLAB SDN (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05770024
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Anticipated Duration (Months): 36.9
• Patients Per Site Per Month: 40.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Subjects Undergoing Diagnostic Imaging Tests	Other: imaging tests

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging
• Actual Study Start Date: Sep 3, 2020
• Actual Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

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 [1-36 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Synlab SDN	Naples		Italy	80143

Sponsors and Collaborators

• IRCCS SYNLAB SDN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IRCCS SYNLAB SDN
• ClinicalTrials.gov Identifier: NCT05770024
• Other Study ID Numbers: 10/20
• First Posted: Mar 15, 2023
• Last Update Posted: Mar 15, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 15, 2023