Cardiac DiseaseNCT04068987
Parametric Mapping in Paediatric Magnetic Resonance Imaging
An observational study of Cardiac Disease and Pediatric Disease, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Pediatric Disease, Cardiomyopathies
- What is being tested?
- MRI parametric mapping
- How many people
- 250 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Aug 2019to 1 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. Healthy Volunteers 2. Patients with suspected or confirmed cardiac disease undergoing clinically indicated MRI.
Who may be able to join
- Healthy volunteers
- Paediatric patients <=18 years of age with suspected or confirmed cardiac disease undergoing clinically indicated MRI
Who cannot join
- Unstable or uncooperative patients that cannot tolerate MRI
- Patients with contraindications for MRI (e.g. patients with implanted devices that are not MRI compatible)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Radiology, Hong Kong Children's Hospital
Hong Kong, 00000
Kenneth Cheung, MBBS, +85235133035, knnth.c@gmail.com
Kenneth Cheung, MBBS
About this study
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.
Read more
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.
Read the 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
- recruit healthy volunteers as controls to establish normal local reference ranges for parametric mapping values
- recruit patients undergoing clinically indicated cardiac MRI to perform parametric mapping, and compare the parametric mapping values between normal controls and patients.
- Being tested
- MRI parametric mapping
- Keywords
- magnetic resonance imaging, parametric mapping
- Medical subject headings
- Heart Diseases, Cardiomyopathies, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI parametric mappingDiagnostic test
Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2* mapping, ECV mapping) to determine the MR signal characteristics of the body
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: MRI parametric mapping | |
| Children undergoing clinically indicated cardiac MRI | Patients who are scheduled to have a clinically indicated cardiac MRI Receives: Diagnostic Test: MRI parametric mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parametric mapping values of normal subjects and patients
Parametric mapping values are generated upon completion of the MR sequence
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Aug 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth CHEUNG, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068987
- Sponsor's protocol ID
- HKCH-REC-2019-014
- Status last verified
- Feb 2020
- First submitted
- 21 Aug 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised patient data can be shared upon request
Publications
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.
PubMed 28992817Kim 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.
PubMed 28096723Riesenkampff 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.
PubMed 25657297Anderson 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.
PubMed 22014495
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parametric Mapping in Paediatric Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04068987
- Acronym / sponsor ID
- HKCH-REC-2019-014
- Keywords
- magnetic resonance imaging, parametric mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- recruit healthy volunteers as controls to establish normal local reference ranges for parametric mapping values
- recruit patients undergoing clinically indicated cardiac MRI to perform parametric mapping, and compare the parametric mapping values between normal controls and patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Diagnostic Test: MRI parametric mappingHealthy 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 | – | Diagnostic Test: MRI parametric mappingPatients who are scheduled to have a clinically indicated cardiac MRI |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. Healthy Volunteers 2. Patients with suspected or confirmed cardiac disease undergoing clinically indicated MRI.
Key inclusion criteria (2 listed)
- Healthy volunteers
- Paediatric patients <=18 years of age with suspected or confirmed cardiac disease undergoing clinically indicated MRI
Key exclusion criteria (2 listed)
- Unstable or uncooperative patients that cannot tolerate MRI
- Patients with contraindications for MRI (e.g. patients with implanted devices that are not MRI compatible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI parametric mappingMagnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2* mapping, ECV mapping) to determine the MR signal characteristics of the body | Diagnostic test | Children undergoing clinically indicated cardiac MRI, Healthy Volunteers |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 28992817Messroghli 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.
- Background: PubMed 28096723Kim 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.
- Background: PubMed 25657297Riesenkampff 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.
- Background: PubMed 22014495Anderson 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.
- Individual participant dataSharing planned: No. Anonymised patient data can be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Pediatric Disease, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Cheung, MBBS (+852 35136084, cky630a@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parametric mapping values of normal subjects and patients (time frame: through study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068987, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.