Validation of a novel three-dimensional ultrafast cardiac MRI protocol in adolescents: a non-inferiority study compared with the 2D gold standard

Background Cardiac magnetic resonance (CMR) is the gold standard for assessing cardiac anatomy and function. However, long acquisition times and multiple breath-holds pose significant challenges in pediatric imaging. Objective To perform a non-inferiority analysis comparing a novel three-dimensional (3D) ultrafast CMR protocol against the conventional two-dimensional (2D) gold standard for evaluating cardiac function, strain, and tissue characterization in adolescents. Materials and Methods Thirty-nine adolescents (mean age 12.2 ± 2.6 years) underwent both a standard 2D protocol and a 3D ultrafast protocol at 3.0 T. The 3D protocol comprised Enhanced Sensitivity Encoding by Static Outer Volume Subtraction (ESSOS) cine and 3D Late Gadolinium Enhancement (LGE). Image quality and diagnostic confidence were compared. A pre-specified non-inferiority margin (Δ) was used to assess functional and strain parameters. Agreement was evaluated using Bland-Altman analysis and intraclass correlation coefficients (ICCs). Results The total scan time was significantly shorter for the 3D protocol compared to the 2D protocol (75.8 ± 10.0 s vs. 734.4 ± 19.6 s, P < 0.05). Image quality scores were comparable between protocols (median score 4.0, P = 0.74). The 3D protocol demonstrated statistical non-inferiority for all functional and strain metrics. Bland-Altman analysis showed minimal bias for key parameters, and the 95% confidence intervals for differences met the pre-specified non-inferiority margins.ICCs indicated good to excellent agreement for all parameters. Conclusion The novel 3D ultrafast CMR protocol is non-inferior to the conventional 2D gold standard for quantitative assessment of cardiac function and strain in adolescents. It offers comparable image quality with significantly reduced acquisition times, potentially improving clinical feasibility in pediatric populations.