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临床试验/NCT07029789
NCT07029789已完成不适用

Clinical Evaluation of Deep Learning-Enhanced Super-Resolution Single-Beat CMR: Prospective Comparison Study

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
Diagnostic interchangeability

研究概览

简要总结

Deep learning super-resolution reconstruction is an emerging technique that enhances the resolution of cardiac magnetic resonance (CMR) scans beyond the original acquisition through post-processing. This study investigates whether a deep learning-based single-beat super-resolution CMR protocol-including cine, T2-STIR, and LGE sequences-can provide diagnostic equivalence to a standard segmented CMR protocol. Total scan time, diagnostic confidence, and diagnostic interchangeability are compared between protocols, with particular focus on wall motion abnormalities, myocardial edema, pericardial effusion, late gadolinium enhancement and final diagnosis. The goal is to assess diagnostic interchangeability while improving efficiency and motion robustness.

详细描述

Cardiac magnetic resonance (CMR) is the gold standard for non-invasive assessment of myocardial diseases, providing comprehensive information through e.g. cine imaging, T2-weighted sequences, and late gadolinium enhancement (LGE). Conventional CMR protocols typically rely on segmented (multi-shot) acquisitions over multiple heartbeats and require repeated breath-holds, which can limit patient comfort and compliance. While these segmented sequences offer high spatial resolution, they are prone to motion and respiratory artifacts-particularly in patients with arrhythmias or dyspnea-and contribute to long total examination times.

Recent advances in deep learning (DL) reconstruction techniques have enabled substantial acceleration of segmented CMR sequences, particularly for cine and LGE imaging. These approaches effectively reduce acquisition time but still rely on regular cardiac rhythm and adequate breath-holding capacity, limiting their applicability in more challenging patient populations. In contrast, single beat (or: single-shot) imaging acquires data within a single heartbeat, offering a motion-robust alternative, though at the cost of lower spatial resolution.

Efforts to streamline CMR are ongoing, with some studies proposing to reduce comprehensive exam times to 30 minutes or less. In parallel, full DL-based reconstruction MRI protocols are being increasingly explored across MRI domains, including neuroimaging and musculoskeletal imaging. Applying deep learning super-resolution to CMR, particularly in combination with single-beat acquisitions with the option of free-breathing acquisition, may enhance both speed and robustness.

This prospective investigates whether a deep learning-based single-beat super-resolution CMR protocol - including single-shot cine, T2-STIR, and LGE sequences in both short- and long-axis views - can provide diagnostic interchangeability to a standard segmented protocol. All participants undergo both protocols during the same exam session. Total scan times are compared between protocols using Student's t-test. Three blinded readers evaluate predefined diagnostic categories including wall motion abnormalities, pericardial effusion, myocardial edema, LGE, and the final CMR diagnosis. Generalized estimating equations with bootstrapped 95% confidence intervals and a predefined equivalence margin of ±5% was used for the interchangeability analysis. Agreement in categorical ratings was evaluated using Cohen's Kappa and Fleiss' Kappa, as appropriate. Diagnostic confidence was rated on a 5-point Likert scale.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical indication for CMR
  • Aged 18 years or older.
  • Willing to participate in the study.
  • Able and willing to provide signed informed consent.

排除标准

  • Pregnant or breastfeeding women
  • Non-removable magnetic metallic implants, prosthetic devices, or extensive tattoos covering large areas of the body
  • Presence of a non-MRI safe pacemaker or neurostimulator

结局指标

主要结局

Diagnostic interchangeability

时间窗: May - December 2024

Assessment of diagnostic interchangeability between the deep learning-based single-beat SuperRes CMR protocol and the standard segmented CMR protocol. Diagnostic categories include wall motion abnormalities, pericardial effusion, myocardial edema, late gadolinium enhancement, and the final CMR diagnosis. Interchangeability was evaluated using generalized estimating equations with bootstrapped 95% confidence intervals and a predefined equivalence margin of ±5%. For each category, the outcome is expressed as an individual equivalence index (%), defined as the difference in agreement probabilities.

次要结局

  • Scan time(May - December 2024)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Isaak

Radiologist, Radiology Clinic

University Hospital, Bonn

研究点 (1)

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