Parametric Mapping in Paediatric Magnetic Resonance Imaging

• Conditions: Cardiac Disease; Cardiomyopathies; Pediatric Disease; Congenital Disorders
• Interventions: Diagnostic Test: MRI parametric mapping

• Registration Number: NCT04068987
• Lead Sponsor: Hong Kong Children's Hospital

Brief Summary

Magnetic resonance imaging (MRI) is increasingly an important tool for diagnosis and management of cardiac diseases in children.

One of the uses of MRI is tissue characterisation, in which the signal characteristics of the cardiac muscle (myocardium) can be determined with special techniques, known as parametric mapping.

There is increasing evidence that parametric mapping may be able to identify regions of scarring in the myocardium, or detection of oedema/inflammation in the setting. This in turn can help predict disease course and add value to the management of patients.

There is also evidence that other structures that are visualised in parametric mapping aside from the heart (e.g. liver and spleen) can also help improve diagnostic accuracy and guide management.

Currently the majority of studies describing the use of parametric mapping is focused on adults, with limited data on its use in children.

The parametric mapping values can also differ amongst different machines, so calibration with normal subjects are also required.

Detailed Description

Magnetic resonance Imaging (MRI) can provide tissue characterisation without radiation and need for invasive biopsy.

Parametric mapping techniques (T1 mapping, extracellular volume fraction, T2 mapping, T2\* mapping) are methods of quantitative analysis of tissue properties, and are currently commercially available.

T1 mapping, extracellular volume fraction (ECV) and T2\* mapping provides knowledge about the tissue properties of the myocardium, interstitium and adjacent structures,and can provide information for diagnosis of fibrosis, inflammatory and infiltrative diseases.

T2 mapping is useful for assessing oedema, which may be useful in monitoring disease activity such as myocarditis.

Parametric mapping has proven clinical utility in iron deposition, amyloid disease, Anderson-Fabry disease and myocarditis.

In addition to assessment of cardiac muscle, tissue characterisation can also be performed in adjacent organs that are included in the field of view of parametric mapping (e.g. liver and spleen).

Parametric mapping may provide important diagnostic information for decision making, patient monitoring and management planning.

The investigators aim to

1. recruit healthy volunteers as controls to establish normal local reference ranges for parametric mapping values

2. recruit patients undergoing clinically indicated cardiac MRI to perform parametric mapping, and compare the parametric mapping values between normal controls and patients.

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Study Start: 2019-08-23
• Study First Posted: 2019-08-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Healthy volunteers
• Paediatric patients <=18 years of age with suspected or confirmed cardiac disease undergoing clinically indicated MRI

Exclusion Criteria

• Unstable or uncooperative patients that cannot tolerate MRI
• Patients with contraindications for MRI (e.g. patients with implanted devices that are not MRI compatible)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	MRI parametric mapping	Healthy volunteers 1. Recruited from the public 2. Patients who have scheduled imaging scans for non-cardiac reasons and without a prior history or suspected history of cardiac disease
Children undergoing clinically indicated cardiac MRI	MRI parametric mapping	Patients who are scheduled to have a clinically indicated cardiac MRI

Primary Outcome Measures

Name	Time	Method
Parametric mapping values of normal subjects and patients	through study completion, up to 2 years	Parametric mapping values are generated upon completion of the MR sequence

Trial Locations

Locations (1)

Department of Radiology, Hong Kong Children's Hospital; 🇭🇰 Hong Kong, Hong Kong