The Effectiveness of 4D Image Acquisition and Post-processing With Vios Works

October 25, 2022 updated by: Michael Poon, Northwell Health

THE EFFECTIVENESS OF 4D IMAGE ACQUISITION AND POST-PROCESSING WITH VIOS WORKS: A Phase Design Prospective Clinical Trial to Assess 4D Software Produced by GE and Arterys for Evaluating Cardiac Disease.

This study aims to evaluate the effectiveness of 4D image acquisition and post-processing with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging scanners. Specifically, the investigators propose to evaluate the following:

  1. Image acquisition time using traditional 2D and new 4D processing techniques;
  2. Image quality for 2D and 4D processing techniques subjectively
  3. Post-processing time for the two techniques.
  4. Correlation of overall Left ventricular and right ventricular volumes and functions and aortic and pulmonic flow studies using the two techniques.
  5. The study will monitor any changes in patient diagnoses or treatment resulting from any differences in interpretations between the two processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Traditional scanning and post-processing of 2D Cardiac Magnetic Resonance images (CMRI) is highly technical and time consuming, with many exams requiring one to two hours to complete. In addition, performance of 2D scans often requires expert technologists working closely with the clinician imaging expert. These factors limit the general clinical utility of current generation cardiac MRI.

In order to address these factors, many researchers began to explore the use of 4D image acquisition and post processing to shorten exam time. These researchers have documented success at these efforts but, to the best of the current investigators' knowledge, such advanced imaging acquisition and post-processing systems are not readily commercially available in the US.

Recently GE teamed with Vios-Works for MRI to provide a cloud-based visualization platform for 4D MRI that provides quantitative and structured reporting in the post processing environment that makes use of advance MR imaging acquisition techniques. The images can be accessed by the interpreter and reviewed and manipulated in order to assess cardiac function and flow retrospectively, which, prior to this innovation, only has been available for computed tomography (CT) generated images.

This investigative team hypothesizes that the use of 4D imaging will result in reduced time for acquisition (approximately 6 minutes as opposed to 1 hour), and improvement of diagnostic capability.

Images will be acquired using the current standard 2D acquisition protocol for routine clinical cardiac MRI. A repeat acquisition will be completed using the new protocol for 4D imaging acquisition. This will require that patient exams be extended in length by six minutes for those enrolled in the study. The investigators will evaluate the image quality of the two techniques and grade them according to a scale of 1 to 3 with 1 being excellent cardiac borders easily identified; 2 - acceptable: cardiac borders acceptably identified; and 3, non-diagnostic. The investigators will specifically focus on the evaluation of cardiac function of both right and left ventricular function as well as flow analysis of both the aortic and pulmonic valves.

For each method, technician time and MD time will be collected. The exam will go through post processing for standard 2D, following by the new 4D post processing technique. Time for post processing will be collected. All subjects who agree will receive both a 2D and a 4D MRI. The investigators will evaluate inter and intra reader reliability by having all readers read the first 15 exams, and then read them a second time after two weeks in a different order Readers showing variation in performance will be retrained on interpretation of 4D MRI before reading scans for the study.

Once readers have been trained, the study will require that all 2D and 4D exams be read by two readers. The exams will be assigned randomly to readers using the Biostatistician Office random assignment services.

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 (Actual)

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.
250

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10011
        • Northwell Health Imaging at Greenwich Village: a Division of Lenox Hill Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • with a valid prescription for Cardiac MRI for the following: Congenital heart disease/Shunts, Valvular heart disease, Pulmonary Hypertension, Aortic Disease, Hypertrophic Cardiomyopathy (HCM)
  • receiving Standard of Care services at the MRI Center
  • consent to participate in the 4D trial

Exclusion Criteria:

Patients with any of the following will be excluded:

  • Pacemaker or ICD implanted
  • ICDs implanted
  • Temporary Pacemakers (e.g. transvenous temporary wires)
  • Leads that are abandoned (capped or retained leads not attached to device)
  • Non-transvenous leads (e.g. epicardial leads)
  • Leads that have no fixation (e.g. floating leads)
  • A lead that is known to be fractured
  • Any other metallic objects that, in the opinion of the safety officer would compromise patient safety

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: All Enrollees

Intervention: Diagnostic test

All enrollees will receive a 4D MRI as a research intervention using imaging software for 4 dimensional images for Cardiac MRI
Device: Imaging software for 4 dimensional images for Cardiac MRI
All enrollees will receive Cardiac MRI scans using Imaging software for 4 dimensional images for Cardiac MRI

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
2D imaging findings and medical diagnoses resulting from images.
Time Frame: Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
Investigators will count the number of study outcomes documented that are related to patient treatment.
Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
4D imaging findings and medical diagnoses resulting from images.
Time Frame: Investigators are expected to interpret the 4D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
Investigators will count the number of study outcomes documented that are related to patient treatment.
Investigators are expected to interpret the 4D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2D Time to scan acquisition
Time Frame: The 2D scan time will be from the time the 2D patient scan starts to the time the 2D patient scan ends. These will be measured on the patient's scheduled scan date.
Investigators will document time to acquire 2D image.
The 2D scan time will be from the time the 2D patient scan starts to the time the 2D patient scan ends. These will be measured on the patient's scheduled scan date.
Time to 2D scan interpretation
Time Frame: The time required for the reader to interpret scan for 2D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Time to interpret 2-D scan interpretation will be from the time the reader starts reading the 2D scan until the time the reader finishes reading the 2D scan.
The time required for the reader to interpret scan for 2D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Intra-reader reliability
Time Frame: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
Each reader will read each scan assigned on two different dates. The reader will be blind to identity of scan. The two readings will be compared for consistency.
The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
Image quality
Time Frame: The reader will record an image score for each exam during interpretation of the scan. The reader will record an image score within one month of scan completion date.
Overall measure of all scan image quality based on standard quality assessment protocol definitions.
The reader will record an image score for each exam during interpretation of the scan. The reader will record an image score within one month of scan completion date.
2D patient recommended treatments
Time Frame: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
The reader will document recommendations for patient treatment based on 2D imaging results
The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
90 day follow up
Time Frame: The interviewer will contact patients with a target date of 90 to 120 days after the exam to obtain the followup information via telephone.
Describe patient follow-up. The interviewer will record the patient follow up by interviewing the patient within 90 to 120 days of the scan and asking what follow up was taken; and by medical record review. Follow up will be recorded and will be compared to recommended follow up.
The interviewer will contact patients with a target date of 90 to 120 days after the exam to obtain the followup information via telephone.
4D Time to scan acquisition
Time Frame: The 4D scan time will be from the time the 4D patient scan starts to the time the 4D patient scan ends. These will be measured on the patients scheduled scan date.
Investigators will document time to acquire 4D image
The 4D scan time will be from the time the 4D patient scan starts to the time the 4D patient scan ends. These will be measured on the patients scheduled scan date.
Time to 4D scan interpretation
Time Frame: The time required for the reader to interpret scan for 4D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Time to interpret 4D scan interpretation will be from the time the reader starts reading the 4D scan until the time the reader finishes reading the 4D scan.
The time required for the reader to interpret scan for 4D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Inter-reader reliability
Time Frame: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
Two readers will read each scan. The readers will be blind to identity of scan. the reader will not know the results reported by the second reader. The two readings will be compared for consistency.
The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
4D patient recommended treatments
Time Frame: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
The reader will document recommendations for patient treatment based on 4D imaging results
The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.

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.
Northwell Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GE Healthcare
Arterys, Inc.

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: Michael Poon, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
February 20, 2018

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.
April 26, 2021

Study Completion (Anticipated)

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.
June 20, 2023

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).
April 3, 2017

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.
April 19, 2017

First Posted (Actual)

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.
April 25, 2017

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.
October 26, 2022

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.
October 25, 2022

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.
October 1, 2022

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.
  • 16-845-LHH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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