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Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique (4D Flow)

T

The Hospital for Sick Children

Status

Terminated

Conditions

Congenital Heart Disease (CHD)

Treatments

Device: 4D PC MRI acquisition

Study type

Interventional

Funder types

Other

Identifiers

NCT02952287
REB1000050375

Details and patient eligibility

About

The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

Full description

Measurement of blood flow in vessels leading to or arising from the heart is one of the key features of Cardiac Magnetic Resonance (CMR). With standard 2D phase contrast (PC) flow measurements, each vessel is measured separately at a predefined location. Planning and scanning can be time consuming while the patient is inside the scanner. In addition, when the scan time is long, the hemodynamics may be assessed at different physiological states. In contrast to a 2D PC acquisition 4D PC captures all the information about blood flow velocities within a 3D anatomical volume. Once this predefined volume has been acquired, the flow within the heart and vessels of interest can be measured at any desired location offline, i.e. after the patient has left the scanner. This is especially advantageous in cases where multiple 2D PC MRI scans are needed such as in congenital heart disease (CHD). In addition to standard measurements, 4D PC provides flow patterns, which might change our current understanding of pathologic flow conditions. Although there has been increasing interest in this new technique, only a few papers have proved its accuracy in adult population. The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

Enrollment

100 estimated patients

Sex

All

Ages

1 day to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All pediatric patients under 18 years of age undergoing CMR with 2D PC flow measurements as a clinically indicated component of the examination at The Hospital for Sick Children, Toronto, ON.
  • Ability to undergo an MRI examination without anesthesia or sedation.
  • Ability to undergo an MRI examination using 'Feed-and-Sleep' technique39

Exclusion criteria

  • Refusal of consent / assent by parent / legal guardian / patient
  • General contraindications for an MRI examination such as non-MRI compatible metallic implants, claustrophobia.
  • Patients who require anaesthesia or sedation for MRI

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Study Participants
Experimental group
Description:
4D PC MRI acquisition
Treatment:
Device: 4D PC MRI acquisition

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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