- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07029789
- Original Trial
Deep Learning Super-Resolution Single-Beat CMR (DL-SB-CMR)
Clinical Evaluation of Deep Learning-Enhanced Super-Resolution Single-Beat CMR: Prospective Comparison Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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NRW
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Bonn, NRW, Germany, 53123
- University Hospital Bonn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical indication for CMR
- Aged 18 years or older.
- Willing to participate in the study.
- Able and willing to provide signed informed consent.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic interchangeability
Time Frame: May - December 2024
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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.
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May - December 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Scan time
Time Frame: May - December 2024
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Comparison of total scan duration between the deep learning-based single-beat SuperRes CMR protocol and the standard segmented CMR protocol.
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May - December 2024
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Isaak, PD Dr., University Hospital Bonn, Germany
- Study Director: Julian Luetkens, Prof., University Hospital Bonn, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-379-BO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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