Performance of Acquisition Automation of Cardiac MRI

Sponsor
University Hospital, Geneva (Other)
Overall Status
Recruiting
CT.gov ID
NCT06012890
Collaborator
(none)
150
1
12
12.5

Study Details

Study Description

Brief Summary

For this study, cardiac MRI examinations performed will be prospectively included and realized either fully automatically or by a specialized radiology technician. The duration of the automated examinations will be compared to the duration of the manual examinations. The number of failed sequences in both study arms (automated and manual) will be recorded and the quality of the cardiac planes will be compared.

Condition or Disease Intervention/Treatment Phase
  • Other: Automation of cardiac MRI acquisition

Detailed Description

The main hypothesis is that fully automated cardiac MRI protocols require shorter overall scan times than manually acquired, human-executed protocols. The objective will be to demonstrate that automating the examination allows to shorten the scan time, leading to increased patient comfort and clinical flexibility. The study's secondary objective will be to demonstrate the non-inferiority of the automated protocol compared to human acquisition in terms of resulting planning quality and error occurrence during slice planning.

Included patients will undergo clinical cMRI following international and national standards:

only the acquisition strategy will vary. The investigators will successively recruit patients presenting for routine cardiac MRI. The acquisition strategy of the MRI - either automated or manual - will alternate to avoid comparison bias.

The MRI protocol will be the same for both arms and consists of standardized sequences acquired before and after contrast administration. Recruitment will be performed at a single location, in the radiology department. Patients will be recruited on a daily, consecutive basis during clinical practice.

No questionnaire will be used for this study. No biological material will be sampled. Observational data about the acquisition process, potential errors, and patient characteristics will be recorded.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Automatic acquisition

Clinical MRI planning performed automatically by an AI-based software

Other: Automation of cardiac MRI acquisition
The intervention will consist of the automation of the cMRI examination.

Manual Acquisition

Clinical MRI planning performed manually by a specialized radiology technician

Outcome Measures

Primary Outcome Measures

  1. Overall scan time [Up to 12 months]

    This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult patient presenting for morphologic and functional assessment of the myocardium by cardiac MRI.

  • Research consent form obtained after information procedure.

  • Complete cardiac MRI protocol performed.

Exclusion Criteria:
  • Patients unable to provide informed consent.

  • Implantable cardiac device

  • Incomplete cardiac examination due to early termination by the patient.

  • Incomplete data on examination parameters (missing forms).

  • Incompatible MRI protocol

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Geneva Geneva Switzerland

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

  • Principal Investigator: Carl Glessgen, MD, Radiologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Glessgen, Medical Doctor, Consultant, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT06012890
Other Study ID Numbers:
  • 2023-01047
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Aug 28, 2023