Real World Evaluation of Lunit INSIGHT MMG Technology

This study is a single-centre prospective observational cohort study designed to assess and compare the sensitivity and specificity of a Lunit INSIGHT MMG assisted human reading to the standard care double human reading process within mammography review at a "one-stop" breast clinic (non-inferiority study). The current imaging reporting process is a sequential double read of mammography and ultrasound (if available) images, by consultant radiologists or radiographers. The first reader produces a report which is then sent to the second reader who reviews it. If the second reader agrees with the first, this is reflected in the second reader's report which translates into a decision for further action; in the event of disagreement, a third reader arbitrates and produces the final report. In the past, breast clinics have had to resort to single reader reporting due to staff shortages and high demand. This results in delays to any further assessments that may be required. It is worth noting however that despite difficulties in meeting the target, the current clinical pathway has proven to be cost effective. The Lunit INSIGHT MMG tool could generate benefits and potential efficiencies if it were introduced to the clinical service as an assistant reader within the mammography reporting process, by replacing one of the two human readers in the current standard of care. Before this can be assessed however, its non-inferiority in combination with a human reader in comparison to standard of care (double human reading) must first be established. This study will aim to address this issue in the first instance, maintaining standard of care for all patients seen within the 2 week wait pathway, by introducing the use of Lunit INSIGHT MMG into one of two arms within this prospective, observational parallel cohort study.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

Non-Inferiority Study

* Women 18 years of age or older.
* Referred to a "one-stop" breast clinic following GP appointment for breast symptoms.

Patient and workforce qualitative studies Patients: as above. Workforce: Clinical staff and other key stakeholders involved in the implementation of Lunit INSIGHT MMG both male and female

• Able to undergo mammography.

Exclusion Criteria:

Non-Inferiority Study

* Men will not be included in this study.
* Women who are not able to tolerate a mammogram or are unable to have one due to physical difficulties in engagement with the technology caused by immobility or being wheelchair bound.

Patient and workforce qualitative studies Patients: as above. Workforce: Has no connection to Lunit INSIGHT MMG implementation irrespective of being male or female