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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
Jamil Kanfoud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring artificial intelligence, magnetic resonance imaging, breast cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 30, 2019
    Last Updated
    February 5, 2019
    Sponsor
    Jamil Kanfoud
    Collaborators
    Brunel University London, First Option Software Ltd.
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    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

    Learn more about this trial

    An Enhanced Artificial Intelligence Breast MRI Interpretation System

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