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Recruiting
NCT05754476
Multi-center Study of Artificial Intelligence Model for Gadolinium-based Contrast Agent Reduction in Brain MRI (MAGNET)
Conditions: Brain Diseases
Sex: All
Healthy volunteers: 1
Enrollment: 3000
Sponsor: Beijing Tiantan Hospital
Location: China
Summary
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.
Eligibility Criteria
Inclusion Criteria: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.Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative.Exclusion Criteria:Patients with contraindications to MR examination.Patients with incomplete MRI data and obvious image artifacts.
Source: ClinicalTrials.gov (NCT05754476). StuddyBuddy aggregates publicly available trial information.