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An Enhanced Artificial Intelligence Breast MRI Interpretation System

A Comparative Single-centre Study to Evaluate an Enhanced Artificial Intelligence Breast MRI Interpretation System in Women Over 20 With Breast Lesions

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03829423
Acronym
IntelliScan
Enrollment
1526
Registered
2019-02-04
Start date
2019-04-30
Completion date
2020-07-31
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

artificial intelligence, magnetic resonance imaging, breast cancer

Brief summary

Interpretation of breast MR images is a very time-consuming process and places a great burden on breast radiologists. This project aims to develop a technical solution that addresses this healthcare challenge by developing a system that is able to automatically interpret breast MR images in order to aid the radiologist in their diagnosis.

Detailed description

Breast cancer is the most common type of cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2015. In the UK, one in five cases of breast cancer results in a fatality. The IntelliScan project aims to develop a technological solution that addresses a significant healthcare challenge. IntelliScan will develop a software system that will be able to interpret breast MR images automatically in order to identify potential breast cancers. Regular MRI screening of the breast is offered to women from the age of 20, who are at higher risk of developing breast cancer. MR image sequences provide a large amount of information to the radiologist and the interpretation of images is a manual process, which is very time consuming. The high number of women eligible for MRI screening combined with the amount of data provided by MRI scans places a great burden on healthcare systems. Therefore, automatisation of this process would greatly relieve this burden and also has the potential to provide more accurate diagnoses. In this first study, the system's user interface as well as the algorithm will be developed using existing MRI scans. Existing MRI scans with known breast anomalies will be used to develop the decision-making basis for the algorithm. The system will then be tested using existing MRI scans without information about possible anomalies and results will be compared to results from the software system currently in use. In addition, the user-friendliness of the system's user interface will also be evaluated.

Interventions

DIAGNOSTIC_TESTBreast MRI interpretation

Analysis and interpretation of breast MRI sequences by a specially developed breast MRI interpretation algorithm

Sponsors

Brunel University London
CollaboratorUNKNOWN
First Option Software Ltd.
CollaboratorUNKNOWN
Jamil Kanfoud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)

Masking description

Retrospective breast MRI datasets with all personal patient information removed

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Breast MRI scans * MRI examinations undertaken at partner NHS Trust in the UK * MRI examinations undertaken on the MRI system currently installed at partner NHS Trust site (since 2008)

Exclusion criteria

* Incomplete breast MRI datasets * Breast MRI without lesions * Breast lesion on MRI not biopsied

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity/specificity of breast interpretation algorithm1 yearSensitivity and specificity of the information provided by the breast interpretation algorithm to be above 90% and 70%, respectively

Secondary

MeasureTime frameDescription
Time required for diagnosis1 yearThe time required to arrive at a diagnosis using IntelliScan should be less than using manual procedures
User-friendliness of IntelliScan system1 yearObviousness score for categorisation of beast lesions (0 \[not obvious\] to 100 \[extremely obvious\]); ease-of-use score for IntelliScan system (0 \[not easy to use\] to 10 \[extremely easy to use\])

Contacts

Primary ContactJamil Kanfoud, M.Eng.
jamil.kanfoud@brunel.ac.uk+44(0)01223940
Backup ContactSusann Wolfram, PhD
s.wolfram@tees.ac.uk+44(0)1223940

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026