Real World Evaluation of Lunit INSIGHT MMG Technology

Breast Cancer Clinical Trial

Official title:

Real World Evaluation of Lunit INSIGHT MMG Technology in a Population of Women With Breast Symptoms Referred to a "One-stop" Breast Clinic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232070
• Other study ID #: Lunit INSIGHT protocol
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Lunit Inc.
• Contact: Mohammad MS Sayeem
• Phone: +44 (0) 20 784 89527
• Email: kitec[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The study has three main objectives, which will be met through separate sub-studies and analyses.

First, it will investigate and compare the performance of the Lunit INSIGHT MMG tool in combination with a human reader, against the current standard of care (two human readers). Quantitative data will be collected from a prospective, observational cohort study which will take place during routine clinical care at the participating site in parallel to standard care. The main aims will be:

1. To assess and compare the sensitivity and specificity of Lunit INSIGHT MMG combined with a single human reader for non-inferiority compared to double human reading

2. To assess and compare the rate of escalation to arbitration (following non-agreement) for non-inferiority of Lunit INSIGHT MMG combined with a single human reader against double human reading

3. To assess clinician reported agreement with the Lunit INSIGHT MMG report

4. To address any differences in performance characteristics as a function of patient age 6 To assess how Lunit score relates to tumour grade on biopsy

Second, the acceptability and perceptions surrounding the AI will be investigated using qualitative data obtained from patient and workforce interviews and questionnaires from the latter. The main aims will be to assess the acceptability of the Lunit INSIGHT MMG tool to patients and the workforce and explore patient and workforce perceptions surrounding it and its implementation in clinical pathways.

Third, a health economic evaluation will be carried out in a cost effectiveness analysis to assess the value of introducing the Lunit INSIGHT MMG tool at a "one-stop" breast clinic. The main aims will be two. The implementation costs of the Lunit Insight MMG tool and costs of a scan read by it, in combination with a human reader, will be compared against the cost of double human readings based on standard practices. In addition, a valuation of outcomes will also be undertaken following the lifetime of the cohort with the use of the Lunit INSIGHT MMG tool compared with standard of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5500
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases

Intervention

Device:
• Lunit INSIGHT MMG
In the Lunit Assisted arm, the radiographers will also be seeing the Lunit INSIGHT MMG reports while reading the mammograms. The standard of care will be followed in all the cases

Locations

Country	Name	City	State
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (3)

Lead Sponsor	Collaborator
Lunit Inc.	King's College London, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity and cost effectiveness of Lunit INSIGHT MMG	To assess and compare the sensitivity and specificity (further follow up or not) of Lunit INSIGHT MMG combined with a single human reader for non-inferiority against double human reading	Jan-Nov 2024
Primary	Acceptability of Lunit INSIGHT MMG to patients and NHS workforce	To assess the acceptability of Lunit INSIGHT MMG to patients and NHS workforce. This will be done through a patient and workforce qualitative study involving in-depth interviews and questionnaires	Jan-Nov 2024
Primary	Cost Effectiveness of introducing Lunit INSIGHT MMG	To assess the cost effectiveness of introducing Lunit INSIGHT MMG at the 'one-stop' breast clinic	Jan-Nov 2024
Secondary	Sensitivity and specificity of the Lunit INSIGHT MMG assisted single Human reading compared to double human reading	The sensitivity and specificity of the Lunit INSIGHT MMG assisted single human reading will be compared to double human reading through ROC curve comparison	Jan-Nov 2024
Secondary	Number and proportion of non-agreement/arbitrations in the Lunit INSIGHT MMG assisted arm vs the Standard of care pathway arm	Chi squared and Wilson tests on the number and proportion of non-agreement/arbitration in the Lunit INSIGHT MMG assisted arm vs the Standard of Care pathway arm	Jan-Nov 2024
Secondary	Correlation between the Lunit INSIGHT MMG abnormality score and the level of confidence of human reader 1 in the Lunit result	Correlation between Lunit INSIGHT MMG abnormality score (percentage continuous) and the level of confidence of human reader 1 in the Lunit result as measured by Likert scale	Jan-Nov 2024
Secondary	Correlation of reader level of concern score	Correlation of reader level of concern score (categorical ordinal) with Lunit INSIGHT MMG abnormality score (percentage continuous). This can be done using tests Kendall's tau or Somers' D if the abnormality percentage are converted to categorical scores	Jan-Nov 2024
Secondary	Investigation of performance of the Lunit assisted arm in sub-categories of patients	Investigation of performance of the Lunit assisted arm in sub-categories of patients for different ages, breast density, BMI, smoking status and family history using ANOVA or Kruskal-Wallis tests	Jan-Nov 2024
Secondary	Comparison of time to final report between the two arms	Comparison of time to final report between the two arms with T-test and Mann-Whitney test.	Jan-Nov 2024