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

NCT07390708 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Index test (AI-ResRad)

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.

DIAGNOSTIC_TEST

Reference test (SpecNeuroRad)

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.

DIAGNOSTIC_TEST

Comparative Index tests: ResRad and AI-SpecNeuroRad

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.

DIAGNOSTIC_TEST

Neurologist Diagnostic Accuracy (Sub-study outcome)

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07390708 on ClinicalTrials.gov