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Real World Evaluation of Lunit INSIGHT MMG Technology

NCT06232070 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5500

Last updated 2024-01-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • King's College London

    collaborator OTHER

  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER

  • Lunit Inc.

    lead INDUSTRY

Principal Investigators

  • Nisha Sharma · The Leeds Teaching Hospital NHS Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232070 on ClinicalTrials.gov