- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03829423
An Enhanced Artificial Intelligence Breast MRI Interpretation System (IntelliScan)
A Comparative Single-centre Study to Evaluate an Enhanced Artificial Intelligence Breast MRI Interpretation System in Women Over 20 With Breast Lesions
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jamil Kanfoud, M.Eng.
- Phone Number: 310 +44(0)01223940
- Email: jamil.kanfoud@brunel.ac.uk
Study Contact Backup
- Name: Susann Wolfram, PhD
- Phone Number: 341 +44(0)1223940
- Email: s.wolfram@tees.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity/specificity of breast interpretation algorithm
Time Frame: 1 year
|
Sensitivity and specificity of the information provided by the breast interpretation algorithm to be above 90% and 70%, respectively
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time required for diagnosis
Time Frame: 1 year
|
The time required to arrive at a diagnosis using IntelliScan should be less than using manual procedures
|
1 year
|
User-friendliness of IntelliScan system
Time Frame: 1 year
|
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])
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steve Dennis, B.Sc., First Option Software
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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