Parametric Mapping in Paediatric Magnetic Resonance Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-23

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magnetic Resonance Elastography in Infants

NCT02201472

Liver Disease

TERMINATED NA

Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

NCT06065215

Lung Function BPD - Bronchopulmonary Dysplasia

RECRUITING

Pulmonary MRI Using Ultra Short /Zero TE Sequences

NCT06097741

Image

COMPLETED NA

Low-field Magnetic Resonance Imaging in Pediatric Post Covid-19

NCT05445531

COVID-19 COVID-19 Respiratory Infection Long COVID

UNKNOWN NA

Respiratory Motion Analysis in Children With MRI

NCT00367354

Congenital Disorders

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Disease Pediatric Disease Cardiomyopathies Congenital Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Volunteers

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

MRI parametric mapping

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2\* mapping, ECV mapping) to determine the MR signal characteristics of the body

Children undergoing clinically indicated cardiac MRI

Patients who are scheduled to have a clinically indicated cardiac MRI

MRI parametric mapping

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2\* mapping, ECV mapping) to determine the MR signal characteristics of the body

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI parametric mapping

Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2\* mapping, ECV mapping) to determine the MR signal characteristics of the body

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes