- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061822
Artificial Intelligence Delivered Cardiac Magnetic Resonance - Prospective Validation (AID-MR)
Cardiac MRI (CMR) scanning allows doctors to create detailed images of the heart. However, the need for experienced cardiac radiographers to perform each scan can make CMR's delivery difficult, and some patients in the UK wait more than half a year for a scan. These radiographers must take pictures of different part of the heart, termed "views", each of which must be precisely positioned.
The investigators believe they can revolutionise CMR, by using artificial intelligence to automatically position the views so radiographers can focus on more difficult tasks.
The investigators have used a retrospective database of pseudonymised (anonymised and linked) CMR scans at our hospital to create these artificial intelligence (AI) algorithms, and they have validated them retrospectively on previous studies. The investigators now wish to test the algorithms prospectively.
In this study, the investigators will recruit patients undergoing clinical CMR scans. In addition to the routine images acquired by expert radiographers, the investigators will require a duplicate set of images, positioned and planned by the AI algorithms.
The investigators will then compare, within each patient, the AI-planned and expert-radiographer-planned scanning in terms of both speed and image quality.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James P Howard, MB BChir PhD
- Phone Number: +44 207 594 5735
- Email: james.howard1@imperial.ac.uk
Study Locations
-
-
-
London, United Kingdom
- Recruiting
- Imperial College Healthcare NHS Trust
-
Contact:
- James P Howard, MB BChir PhD
- Phone Number: +447841124459
- Email: james.howard1@imperial.ac.uk
-
Principal Investigator:
- James P Howard, MB BChir PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (aged at least 18 years)
Exclusion Criteria:
- Children (patients below age 18).
- Pregnant patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-planned images acquired
|
An AI algorithm will be used to automatically position (plan) the scan planes used in a cardiac MRI scan.
The resultant images will be compared with standard radiographer-positioned images.
|
|
Active Comparator: Radiographer-planned images acquired
|
An AI algorithm will be used to automatically position (plan) the scan planes used in a cardiac MRI scan.
The resultant images will be compared with standard radiographer-positioned images.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time taken to acquire images
Time Frame: During the MRI scan
|
The time taken in seconds from the beginning of the planning process, until the last planned images has been fully acquired.
|
During the MRI scan
|
|
Image quality
Time Frame: During the MRI scan
|
Quality of acquired images (AI-planning versus radiographer planning) assessed by level 3 cardiac MRI accredited doctors, by asking them to choose whether (a) the AI-acquired image is of higher diagnostic quality, (b) the radiographer-acquired image is of higher diagnostic quality, or (c) the AI- and radiographer-acquired images are of identical diagnostic quality.
|
During the MRI scan
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James P Howard, MB BChir PhD, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23HH8238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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