Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time (THAITI-V)

February 25, 2025 updated by: Istituto Auxologico Italiano

Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.

Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".

THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Italy
      • Milan, Italy
        • Istituto Auxologico Italiano IRCCS

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

No

Description

Inclusion Criteria:

  • Patients in whom CMR-LGE is performed for a clinical reason
  • Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
  • Both sexes
  • Any age
  • Availability of serum creatinine, measured within one month prior to CMR
  • Provision of the written informed consent

Exclusion Criteria:

  • Non-contrast CMR
  • First-pass perfusion stress-CMR
  • Absolute contraindication to CMR
  • Inadequate overall image quality

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Operator-set TI (control group)
During the cardiovascular magnetic resonance scan, the TI is set by an experienced human operator as per standard clinical practice
Experimental: THAITI-set TI
During the cardiovascular magnetic resonance scan, the TI is set by the experimental software
Device: THAITI software

THAITI is an AI-based software which predicts on the fly personalised TI for late gadolinium enhancement imaging during cardiovascular magnetic resonance scans.

The clinical investigators will be provided by the computer scientists investigators with a software, based on the developed AI model. During the CMR in the experimental group, investigators will input patients' data on the software (e.g. age, sex, dose of contrast…). The software will provide a TI value to be input in the MRI scanner. TI will be set accordingly to the AI prediction. A LGE series of 3 long axis (4-, 2- and 3-chambers view) and a short-axis stack will be acquired.

For all the patients, a doctor expert in CMR will be at the scanner and quality check the images in real time. Every image where the myocardium is not optimally nulled will be repeated with a TI set by the CMR doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Images quality proportion
Time Frame: At examination
Proportion of images with optimal/good quality
At examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
contrast-enhancement ratio
Time Frame: At examination
Contrast-Enhancement ratio (CER)
At examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

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)

November 11, 2024

Primary Completion (Actual)

December 12, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C335

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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