Parametric Mapping in Paediatric Magnetic Resonance Imaging

February 11, 2020 updated by: Kenneth CHEUNG, Hong Kong Children's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

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

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • Department of Radiology, Hong Kong Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kenneth Cheung, MBBS

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Healthy Volunteers
  2. Patients with suspected or confirmed cardiac disease undergoing clinically indicated MRI.

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: MRI parametric mapping
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
Diagnostic test: MRI parametric mapping
Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2* mapping, ECV mapping) to determine the MR signal characteristics of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parametric mapping values of normal subjects and patients
Time Frame: through study completion, up to 2 years
Parametric mapping values are generated upon completion of the MR sequence
through study completion, up to 2 years

Collaborators and Investigators

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

Sponsor

Hong Kong Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 23, 2019

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCH-REC-2019-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Anonymised patient data can be shared upon request

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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