Parametric Mapping in Paediatric Magnetic Resonance Imaging

NCT04068987 | Unknown

• 1 other identifier: HKCH-REC-2019-014
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Pediatric Disease; Cardiomyopathies; Congenital Disorders

Keywords

magnetic resonance imaging; parametric mapping

Outcome Measures

Primary Outcomes (1)

• Parametric mapping values of normal subjects and patients

  Parametric mapping values are generated upon completion of the MR sequence

  through study completion, up to 2 years

Study Arms (2)

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

Children undergoing clinically indicated cardiac MRI

Patients who are scheduled to have a clinically indicated cardiac MRI

Diagnostic Test: MRI parametric mapping

Interventions

MRI parametric mapping 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; Healthy Volunteers

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Department of Radiology, Hong Kong Children's Hospital

Hong Kong, 00000, Hong Kong

RECRUITING

Related Publications (4)

• Messroghli DR, Moon JC, Ferreira VM, Grosse-Wortmann L, He T, Kellman P, Mascherbauer J, Nezafat R, Salerno M, Schelbert EB, Taylor AJ, Thompson R, Ugander M, van Heeswijk RB, Friedrich MG. Clinical recommendations for cardiovascular magnetic resonance mapping of T1, T2, T2* and extracellular volume: A consensus statement by the Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI). J Cardiovasc Magn Reson. 2017 Oct 9;19(1):75. doi: 10.1186/s12968-017-0389-8.

  PMID: 28992817 BACKGROUND

• Kim PK, Hong YJ, Im DJ, Suh YJ, Park CH, Kim JY, Chang S, Lee HJ, Hur J, Kim YJ, Choi BW. Myocardial T1 and T2 Mapping: Techniques and Clinical Applications. Korean J Radiol. 2017 Jan-Feb;18(1):113-131. doi: 10.3348/kjr.2017.18.1.113. Epub 2017 Jan 5.

  PMID: 28096723 BACKGROUND

• Riesenkampff E, Messroghli DR, Redington AN, Grosse-Wortmann L. Myocardial T1 mapping in pediatric and congenital heart disease. Circ Cardiovasc Imaging. 2015 Feb;8(2):e002504. doi: 10.1161/CIRCIMAGING.114.002504. No abstract available.

  PMID: 25657297 BACKGROUND

• Anderson LJ. Assessment of iron overload with T2* magnetic resonance imaging. Prog Cardiovasc Dis. 2011 Nov-Dec;54(3):287-94. doi: 10.1016/j.pcad.2011.07.004.

  PMID: 22014495 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Cardiomyopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Kenneth Cheung, MBBS

CONTACT

+852 35136084; cky630a@ha.org.hk

Kenneth Cheung, MBBS

CONTACT

+852 91516753; knnth.c@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: August 23, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)