NCT06578988

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25,000 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Cancer, Breast

Interventions

Type	Name	Description
PROCEDURE	Mammography Images	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-04-01
• Completion: 2025-10-01
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: United Kingdom