An Enhanced Artificial Intelligence Breast MRI Interpretation System (IntelliScan)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breast MRI interpretation
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring artificial intelligence, magnetic resonance imaging, breast cancer
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
Sites / Locations
Outcomes
Primary Outcome Measures
Sensitivity/specificity of breast interpretation algorithm
Sensitivity and specificity of the information provided by the breast interpretation algorithm to be above 90% and 70%, respectively
Secondary Outcome Measures
Time required for diagnosis
The time required to arrive at a diagnosis using IntelliScan should be less than using manual procedures
User-friendliness of IntelliScan system
Obviousness 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])
Full Information
NCT ID
NCT03829423
First Posted
January 30, 2019
Last Updated
February 5, 2019
Sponsor
Jamil Kanfoud
Collaborators
Brunel University London, First Option Software Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03829423
Brief Title
An Enhanced Artificial Intelligence Breast MRI Interpretation System
Acronym
IntelliScan
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jamil Kanfoud
Collaborators
Brunel University London, First Option Software Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
artificial intelligence, magnetic resonance imaging, breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Masking Description
Retrospective breast MRI datasets with all personal patient information removed
Allocation
N/A
Enrollment
1526 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Breast MRI interpretation
Intervention Description
Analysis and interpretation of breast MRI sequences by a specially developed breast MRI interpretation algorithm
Primary Outcome Measure Information:
Title
Sensitivity/specificity of breast interpretation algorithm
Description
Sensitivity and specificity of the information provided by the breast interpretation algorithm to be above 90% and 70%, respectively
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time required for diagnosis
Description
The time required to arrive at a diagnosis using IntelliScan should be less than using manual procedures
Time Frame
1 year
Title
User-friendliness of IntelliScan system
Description
Obviousness 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])
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamil Kanfoud, M.Eng.
Phone
+44(0)01223940
Ext
310
Email
jamil.kanfoud@brunel.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Susann Wolfram, PhD
Phone
+44(0)1223940
Ext
341
Email
s.wolfram@tees.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Dennis, B.Sc.
Organizational Affiliation
First Option Software
Official's Role
Study Director
12. IPD Sharing Statement
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An Enhanced Artificial Intelligence Breast MRI Interpretation System
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