Multi-center Study of Artificial Intelligence Model for Gadolinium-based Contrast Agent Reduction in Brain MRI (MAGNET) (MAGNET)

March 2, 2023 updated by: Yaou Liu, Beijing Tiantan Hospital

Multi-center and Prospective Cohort Study of Artificial Intelligence Model for Gadolinium-based Contrast Agent Reduction in Brain MRI (MAGNET)

MAGNET is a multi-center and prospective study to minimize Gadolinium-based Contrast Agent (GBCA) combining novel artificial intelligence (AI) methods with pre-contrast images and/or low-dose images to synthesize virtual contrast-enhanced T1 (vir-T1c) images, based on a large clinical and MRI database and subsequently validated for its clinical value. MRI examinations for patients included T1-weighted images (T1WI) before and after contrast agent administration and at two dose levels: low-dose (10% or 25%) and full-dose (100%), T2-weighted images (T2WI), fluid-attenuated inversion recovery (FLAIR), and diffusion-weighted imaging sequences (DWI) and the computed apparent diffusion coefficient (ADC), all either acquired three dimensional [3D] or two dimensional [2D]). The standard dose of intravenous gadolinium contrast agent was 0.1mmol/kg(body weight) by manual injection or automatic injection with a high-pressure syringe at a flow rate of 4mL/s.The sequence parameters used for the 3DT1WI scans must be consistent, and the standard for intravenous injection of gadolinium contrast agent is 0.1mmol/kg (body weight), administered either manually or automatically with a high-pressure syringe at a rate of 4mL/s.

Additionally, arterial spin labeling (ASL), amide-proton transfer chemical exchange saturation transfer (APT-CEST), susceptibility-weighted imaging (SWI), or quantitative susceptibility mapping (QSM) can be acquired at the same time if the conditions permit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

MRI with GBCA is an indispensable part of imaging exams for brain disease diagnosis. Generally, GBCA is safe, with a few mild side effects since GBCAs received FDA approval in 1989. There are numerous issues that challenge the current practice of widespread use of GBCA. GBCA can trigger nephrogenic systemic fibrosis(NSF) under particular circumstances, cause allergic reactions, may increase the risk of fetal death, and accumulate in the brain such as the dentate nucleus and globus pallidus. Efforts need to be made to reduce dose while still maintaining diagnostic capabilities. Artificial intelligence (AI) techniques have shown great potential in medical fields. Deep learning (DL), a branch of AI, has been applied to image segmentation, computer-aided diagnosis, and reduce GBCA dose.

This study intends to build a prospective brain MRI dataset including patients with suspected or known brain abnormalities to minimize the use of GBCA. Then train DL models to process pre-contrast images and/or low-dose T1 images to predict virtual contrast-enhanced T1 (vir-T1c) images, taking the full-dose images as the reference standard. Later quantitatively and qualitatively evaluating and comparing vir-T1c images from DL models about clinical diagnostic performance, focusing on lesion detection, diagnosis, and therapy, to explore a DL model universal, provide enhanced images faster and more convenient in clinical practice. To minimize the use of GBCA, we will:

  1. Use novel artificial intelligence (AI) methods with pre-contrast images including conventional (T1WI, T2WI, FLAIR, DWI/ADC), new physiological MRI techniques (ASL, APT-CEST, SWI/QSM) by adding physiological information from perfusion as well as metabolic and susceptibility imaging, and/or low-dose images (10% or 25%) to synthesize vir-T1c images;
  2. Quantify when (in which patients and at what follow-up times) GBCA can be omitted or minimized without influencing brain disease diagnosis and treatment evaluation for doctor raters and therefore patient prognosis.

This study does not limit manufacturers including 1.5T and 3.0T scanners， or kinds of GBCAs.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Siyao Xu, Postgraduate
  • Phone Number: +86 17780540030
  • Email: xusiyao97@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

To reflect the daily practices, this study includes all patients with suspected or known brain diseases requiring MRI exams with GBCAs at the beginning of the study.

Description

Inclusion Criteria:

  1. Patients with suspected or known brain diseases including tumors, vascular disorders, inflammatory diseases, neurodegenerative diseases and trauma, follow-up, routine brain, and others requiring MRI exams with GBCAs.
  2. Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative.

Exclusion Criteria:

  1. Patients with contraindications to MR examination.
  2. Patients with incomplete MRI data and obvious image artifacts.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brain Diseases
This study does not limit the kinds of brain diseases. The cohort includes patients with suspected or known brain diseases including tumors, vascular disorder, inflammatory disease, neurodegenerative diseases and trauma, follow-up, routine brain, and others requiring MRI exams with GBCAs.
Other: Low-dose GBCA levels
MRI examinations for patients at two dose levels: low-dose (10% or 25%）can be chosen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative metrics
Time Frame: after training and applying of the proposed deep learning model, an average of 1 year
To quantitatively describe the discrepancies between the vir-T1c and the full-dose images by measuring the peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM). The PSNR measures the voxelwise difference and the PSNR range is between -1 and 1. The SSIM compares nonlocal structural similarity and the minimum value of PSNR is 0. The metrics will be reported in separate(e.g.,SSIM, 0.90; PSNR,42 in vir-T1c, SSIM, 0.94; PSNR,45 in full-dose images).
after training and applying of the proposed deep learning model, an average of 1 year
qualitative assessments
Time Frame: after training and applying of the proposed deep learning model, an average of 15 months

To qualitatively describe discrepancies between the vir-T1c and full-dose images by evaluating enhancement degree, homogeneity, and pattern.

Firstly, zero indicates no intracranial or non-enhancing lesion. For enhancement degree, 1 indicates mild enhancement, 2 indicates moderate enhancement, and 3 indicates clear enhancement.

For enhancement homogeneity, 1 indicates heterogeneous enhancement, 2 indicates mildly heterogeneous enhancement, and 3 indicates homogeneous enhancement.

For enhancement pattern, 1 indicates mass enhancement（proportion enhancement more than 50%）, 2 indicates nodular enhancement (proportion enhancement less than or equal to 50%）, 3 indicates ring enhancement, 4 indicates linear enhancement, and 5 indicates other enhancement.
after training and applying of the proposed deep learning model, an average of 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical effects
Time Frame: after training and applying of the proposed deep learning model, an average of 18 month

To describe whether vir-T1c images combing other sequences affect diagnosis or treatment according to evaluation of neuroradiologist and neurologist from 1 to 5 scores.

Zero indicates enhancement error and can not be used. 1 indicates non-diagnostic. 2 indicates affecting diagnosis or treatment significantly. 3 indicates affecting diagnosis or treatment moderately. 4 indicates no affecting diagnosis or treatment almost. 5 indicates no affecting diagnosis or treatment completely.
after training and applying of the proposed deep learning model, an average of 18 month

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Yaou Liu, PhD, Study Principal Investigator

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)

March 29, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2021-184-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical and MR data can be shared.

IPD Sharing Time Frame

Within 5 years after the end of the trial.

IPD Sharing Access Criteria

Neurologist and radiologist who submitting an application to Prof. Liu.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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