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

August 23, 2021 updated by: Shi-Joon Yoo, The Hospital for Sick Children
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Study Participants
4D PC MRI acquisition
Device: 4D PC MRI acquisition
Flow-sensitive 4D-MRI acquisitions will be synchronized to the heart rate and breathing using prospective ECG-gating and adaptive diaphragm navigator gating41. The MRI sequence will consist of a segmented k-space spoiled gradient echo sequence with interleaved 3D velocity encoding. Data will be acquired in a sagittal oblique 3D data volume individually adapted to include the heart and the thoracic and upper abdominal vessels of interest like ascending, transverse and descending aorta, main and branch pulmonary arteries, pulmonary veins, superior and inferior vena cava, celiac and superior mesenteric vessels. Velocity encoding (VENC) will be set at 150-500 cm/sec to encompass flow in various vessels.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pearson´s correlation coefficient (r)
Time Frame: Six months
The association of variables (stroke volumes as measured with 2D and 4D flow, regurgitation fractions) will be investigated with Pearson´s correlation coefficient (r). P values of <0.05 will be considered significant.
Six months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shi-Joon Yoo, MD, The Hospital for Sick Children

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB1000050375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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