An Enhanced Artificial Intelligence Breast MRI Interpretation System

NCT ID: NCT03829423

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers
Retrospective breast MRI datasets with all personal patient information removed

Interventions

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Breast MRI interpretation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brunel University London

UNKNOWN

Sponsor Role collaborator

First Option Software Ltd.

UNKNOWN

Sponsor Role collaborator

Jamil Kanfoud

OTHER

Sponsor Role lead

Responsible Party

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Jamil Kanfoud

Head of Brunel Innovation Centre

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Steve Dennis, B.Sc.

Role: STUDY_DIRECTOR

First Option Software

Central Contacts

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Jamil Kanfoud, M.Eng.

Role: CONTACT

+44(0)01223940 ext. 310

Susann Wolfram, PhD

Role: CONTACT

+44(0)1223940 ext. 341

Other Identifiers

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4901

Identifier Type: -

Identifier Source: org_study_id

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