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Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting

NCT06578988 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 25000

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Cancer, Breast

Interventions

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.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-04-01
Completion
2025-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578988 on ClinicalTrials.gov