Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting
Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting - A Retrospective Study (AI-BRACE)
Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results.
It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic.
It is therefore important to test the performance of these systems in this alternative context.
This study will use retrospective data, from where it is possible to determine ground truth outcomes with greater confidence, accessing relatively large volumes of data with less patient burden when compared to prospective studies. This important cohort of patients has been less investigated to date, mainly because symptomatic data is typically more difficult to curate than screening data where key data is methodically prospectively collected.
The proposed work will be carried out in collaboration with a selected AI vendor and local clinical teams to define optimal use case scenarios for the symptomatic breast clinic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with breast symptoms are referred from primary care to symptomatic breast clinics, often under the two-week-wait cancer pathway. Clinicians assess the patient's breast symptoms by looking at the patient's personal and family history of cancer, conducting a physical examination, and referring the patient for imaging as required.
Ultrasound and / or mammography are typically performed and reported by the imaging team at the same visit, with biopsy performed when indicated. This service is an important part of cancer care provision, with approximately half of the breast cancers diagnosed presenting via the symptomatic service rather than identified at screening.
It is important to note that cancers diagnosed symptomatically tend to be larger and more aggressive with worse outcome than those diagnosed via screening. The volume of referrals to the National Health Service (NHS) symptomatic service has risen over the last decade, placing increased pressure on service delivery, in breast imaging.
Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results. It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic. It is therefore important to test the performance of these systems in this alternative context.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria
- Patients 18 years or older attending symptomatic breast clinic.
- Mammography images, including both full field two-dimensional digital mammography and digital breast tomosynthesis.
Dates of attendance will be from January 2015* to December 2019 at the lead data collection site. Dates of collection may be different at the other sites depending on local data curation consideration but will be a minimum of 2 years prior to study start to allow determination of ground truth.
- If any mammography images prior to 2015 should be available at the lead site, these will be collected as well (a maximum of 3). Prior mammograms will also be collected at the other sites if available, depending on local PACS set-up.
Exclusion criteria
- Patients under the age of 18 years.
- Patients on the National data opt out.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Symptomatic breast clinic.
Patients 18 years or older attending symptomatic breast clinic from January 2015 to December 2019.
|
Ultrasound and / or mammography are typically performed and reported by the imaging team at the same visit, with biopsy performed when indicated.
This service is an important part of cancer care provision, with approximately half of the breast cancers diagnosed presenting via the symptomatic service rather than identified at screening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Performance of screening tool on symptomatic data, in terms of sensitivity and specificity.
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subgroup analysis based on ground-truth - Normal; Benign; Malignant.
Time Frame: 18 months
|
This is either normal, benign or malignant.
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- CCR5910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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