Real World Evaluation of Lunit INSIGHT MMG Technology

NCT06232070 | Unknown FDA Device

• 1 other identifier: Lunit INSIGHT protocol
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Sensitivity and specificity of the Lunit INSIGHT MMG assisted single Human reading compared to double human reading

  Jan-Nov 2024

• Number and proportion of non-agreement/arbitrations in the Lunit INSIGHT MMG assisted arm vs the Standard of care pathway arm

  Jan-Nov 2024

• Correlation between the Lunit INSIGHT MMG abnormality score and the level of confidence of human reader 1 in the Lunit result

  Jan-Nov 2024

• Correlation of reader level of concern score

  Jan-Nov 2024

• Investigation of performance of the Lunit assisted arm in sub-categories of patients

  Jan-Nov 2024

Study Arms (2)

Standard Pathway Arm

All participating patients will have their mammograms reported using the standard of care. The mammograms randomised to the Standard Pathway arm will be reported using the current standard of care, which involves two human readers; The readers will be blind to Lunit INSIGHT MMG report

Lunit Assisted Arm

All participating patients will have their mammograms reported using the standard of care. Those randomised to the Lunit assisted arm will also undergo double reader process , ensuring the current standard of clinical care is provided. In addition to that, the Lunit INSIGHT MMG report will also be available to the readers. Within this arm, each reader will be presented with a Likert scale to rank their level of agreement with the Lunit INSIGHT MMG report

Device: Lunit INSIGHT MMG

Interventions

Lunit INSIGHT MMG DEVICE

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

Lunit Assisted Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The symptomatic breast population will be recruited from the breast service 2 week pathway referred to a 'one-stop' breast clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lunit Inc.: lead
• King's College London: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nisha Sharma

  The Leeds Teaching Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad MS Sayeem

CONTACT

+44 (0) 20 784 89527; kitec@kcl.ac.uk

Sarah Hammoudi

CONTACT

+44 (0) 20 784 89527; kitec@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)