A Trial on the Use of Point-of-care Ultrasound in the Assessment of Breast Symptoms

Condition(s) studied

Investigational drug(s) / intervention(s)

Point-of-care ultrasound: Point-of-care ultrasound will be performed on symptomatic breast patients. The images will be analysed by AI

Study summary

The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. The purpose of this study is to evaluate the performance of POCUS for women with focal breast symptoms and to assess the performance of AI to analyze POCUS images. The study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.

Eligibility

Primary outcome measure(s)

• The area under the receiver operating characteristic curve (AUC) for the intervention, compared to that of the comparator — From the last enrolled participant to the end of one-year follow up
  1. The AUC of POCUS compared to SoC 2. The AUC of AI compared to average radiologists on POCUS

Trial sites (1)

More Region Skane trials in Sweden

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