Lunit and U.K.’s Leeds Teaching Hospitals NHS Trust said they have kicked off the "world's first" prospective study of artificial intelligence (AI)-powered breast reading in a symptomatic breast clinic environment, utilizing Lunit INSIGHT MMG.

This initiative aims to revolutionize breast cancer detection, streamline diagnosis, and tackle radiologist shortages by evaluating Lunit INSIGHT MMG's efficacy, an AI mammography analysis solution.

The symptomatic breast clinic is a specialized medical setting that diagnoses individuals with breast-related symptoms. These clinics are vital for timely assessments and diagnoses.

While these clinics commonly adopt a double reporting process, where two doctors read the image, for accuracy, challenges arise from radiologist shortages and burnout.

To address these challenges, Lunit and Leeds Teaching Hospitals are launching an evaluation to establish Lunit INSIGHT MMG's non-inferiority when used with a human reader, compared to the current double human reading approach.

The study, scheduled to run until the end of 2025, will encompass 5,500 mammography cases of women visiting the UK Leeds Teaching Hospitals NHS Trust breast clinic. The participants will be divided into two groups -- one group (2,750 women) will undergo traditional double reading, and another group (2,750 women) will benefit from the expertise of two radiologists aided by Lunit INSIGHT MMG.

The primary objectives of this study include assessing and comparing the sensitivity and specificity of Lunit INSIGHT MMG within the mammography review process.

Additionally, the study will evaluate Lunit INSIGHT MMG's acceptability among patients and the NHS workforce, while determining the cost-effectiveness of implementing the technology within the one-stop breast clinic model.

"Our collaboration with Leeds Teaching Hospitals NHS Trust marks a historic milestone in advancing AI-driven breast cancer reading in symptomatic breast clinic environments," Lunit CEO Suh Beom-seok said. "By fusing our AI technology with Leeds' clinical excellence, we are pioneering an approach that has the potential to elevate accuracy, expedite diagnosis, and alleviate the strain caused by radiologist shortages."

Nisha Sharma, Leeds Teaching Hospitals Breast Screening Program Director, also said, "As breast cancer screening plays a pivotal role in early detection and improved outcomes, innovations like the Lunit INSIGHT MMG AI tool hold immense promise."

"This study has the potential to reshape how we approach breast cancer diagnosis and optimize patient care," Sharma added.

Meanwhile, Lunit is hosting a symposium about the study at the European Society of Breast Imaging (EUSOBI 2023), scheduled from Sep. 28 to 30.

At the symposium, Sharma will present on the topic of "Application of AI in the clinic and prospective clinical initiatives."