Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with known onset.

The study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Stroke team activation

Thrombolysis candidate

Known symptom onset

Disqualifiers

Prior inclusion

Previous MRI in the same course of hospitalization

No resident radiologist on call

Trial population

Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Index test (AI-ResRad)

    Diagnostic test

    Eligible residents will review MRI sequences from the local PACS as they become available. During this process, they will maintain real-time communication-in person or via phone-with the treating neurologist, who will provide relevant clinical information. Simultaneously, the resident will have access to the AI output. Residents will have full access to the patient's electronic medical record and prior imaging. After integrating these inputs, the resident will complete an AI-assisted MRI interpretation using a predefined survey structure.

  • Reference test (SpecNeuroRad)

    Diagnostic test

    Before any MRI sequences have been finalized, the resident will notify the on-call specialist neuroradiologist and pass on the clinical information received from the neurologist. The neuroradiologist will then independently review the MRI sequences as they become available in PACS, without access to the resident's interpretation or the AI results. They will also access the patient's electronic medical record and prior imaging. Once both parties have completed their respective surveys, the resident will call the neuroradiologist to jointly deliver an oral MRI interpretation to the neurologist. The radiologic information system's written radiology report may be completed by the neuroradiologist or the resident, with final sign-off by the neuroradiologist.

  • Comparative Index tests: ResRad and AI-SpecNeuroRad

    Diagnostic test

    Two additional comparative test strategies will be evaluated: * ResRad: Prior to accessing AI results, residents will complete a non-assisted MRI interpretation. * AI-SpecNeuroRad: After completing their initial non-assisted interpretation (SpecNeuroRad), the specialist neuroradiologist will be granted access to the AI output. They will then submit a second interpretation (AI-assisted) using the same survey platform. To enforce internal blinding between non-assisted and AI-assisted interpretations, AI outputs are only revealed upon manual activation, which is timestamped by the system. Interpretation surveys are also timestamped at submission. All non-assisted interpretations must be submitted prior to AI output activation to be considered valid. Cases that violate this timestamp sequence will be excluded from final analyses to ensure methodological integrity.

  • Neurologist Diagnostic Accuracy (Sub-study outcome)

    Diagnostic test

    Simultaneously with the radiologists' MRI interpretations with and without AI assistance according to the study workflow, the neurologist responsible for patient management will complete a similar MRI interpretation survey. The neurologist will first interpret the MRI without AI assistance and subsequently with AI assistance, mirroring the radiologist study workflow. The neurologist will be blinded to the radiologists' interpretations while completing their assessments, and likewise, the radiologists will be blinded to the neurologist's interpretations.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Acute stroke with known onset4 interventions

Trial outcomes

Primary outcomes

1

Composite agreement

Overall agreement is defined as the proportion of patients for whom the AI-ResRad and SpecNeuroRad agree on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.

Time frame
Immediately after the procedure

Secondary outcomes

1

Diagnostic Accuracy

The diagnostic accuracy of the AI-ResRad and ResRad strategies will be reported in terms of sensitivity, specificity, and positive and negative predictive values, using SpecNeuroRad as the reference standard. This will be assessed separately for each of the imaging patterns: 1) DWI lesion; and 2) hemorrhage.

Time frame
immediately after the procedure
2

Comparative Diagnostic Accuracy

Comparative diagnostic accuracy outcomes will be explored between the AI-ResRad and ResRad strategies, using SpecNeuroRad as the reference standard, including the net reclassification index, net benefit, and absolute difference in overall agreement (defined as described above for the primary outcome).

Time frame
immediately after the procedure
3

Concordance SpecNeuroRad

For the AI-SpecNeuroRad strategy, outcomes will include pairwise agreement with the original SpecNeuroRad interpretation, characterization of disagreement cases, and identification of AI-induced reclassifications.

Time frame
immediately after the procedure

Other outcomes

1

Neurologists' Diagnostic Accuracy (Sub-study)

The diagnostic accuracy of the neurologist's interpretations, both without AI assistance and with AI assistance, will be reported in terms of sensitivity, specificity, and positive and negative predictive values, using SpecNeuroRad as the reference standard. Accuracy will be assessed separately for each imaging pattern: (1) DWI lesion and (2) hemorrhage.

Time frame
Immediately after the procedure
2

Neurologists' Composite Agreement (Sub-study)

Overall agreement will be defined as the proportion of patients for whom the neurologist's interpretations (with and without AI assistance) agree with the SpecNeuroRad on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.

Time frame
Immediately after the procedure

Sponsors and contacts

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