Parametric Mapping in Paediatric Magnetic Resonance Imaging

Sponsor
Hong Kong Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04068987
Collaborator
(none)
250
1
39.3
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI parametric mapping

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
250 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Parametric Mapping in Paediatric Magnetic Resonance Imaging
Actual Study Start Date :
Aug 23, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Healthy Volunteers

Healthy volunteers Recruited from the public 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Radiology, Hong Kong Children's Hospital Hong Kong Hong Kong 00000

Sponsors and Collaborators

  • Hong Kong Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kenneth CHEUNG, Associate Consultant, Hong Kong Children's Hospital
ClinicalTrials.gov Identifier:
NCT04068987
Other Study ID Numbers:
  • HKCH-REC-2019-014
First Posted:
Aug 28, 2019
Last Update Posted:
Feb 13, 2020
Last Verified:
Feb 1, 2020
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
Keywords provided by Kenneth CHEUNG, Associate Consultant, Hong Kong Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2020