Clinical trial NCT03829423: An Enhanced Artificial Intelligence Breast MRI Interpretation System
Official title: A Comparative Single-centre Study to Evaluate an Enhanced Artificial Intelligence Breast MRI Interpretation System in Women Over 20 With Breast Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: artificial intelligence
magnetic resonance imaging
breast cancer
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: Brunel University London
name: First Option Software Ltd.
First posted: 2019-02-04
Enrollment: 1526
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity/specificity of breast interpretation algorithm
timeFrame: 1 year
Secondary outcomes:
measure: Time required for diagnosis
timeFrame: 1 year
measure: User-friendliness of IntelliScan system
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: First Option Software
name: Steve Dennis, B.Sc.
role: STUDY_DIRECTOR
References: