Breast CancerNCT06232070
Real World Evaluation of Lunit INSIGHT MMG Technology
An observational study of Breast Cancer and Breast Diseases, run by Lunit Inc. at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Diseases
- What is being tested?
- Lunit INSIGHT MMG
- Type of treatment
- Medical device
- How many people
- 5,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2024to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The symptomatic breast population will be recruited from the breast service 2 week pathway referred to a 'one-stop' breast clinic
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Leeds Teaching Hospitals NHS Trust
Leeds
Dr Nisha Sharma, leedsth-tr.breastscreeningresearch@nhs.net
Aneesha Qadeer, leedsth-tr.breastscreeningresearch@nhs.net
About this study
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
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.
Read more
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.
Read the detailed 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:
- 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
- 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
- To assess clinician reported agreement with the Lunit INSIGHT MMG report
- 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.
- Conditions
- Breast Cancer, Breast Diseases
- Being tested
- Lunit INSIGHT MMG
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunit INSIGHT MMGDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Lunit INSIGHT MMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Jan-Nov 2024
Secondary outcomes (6)
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
Measured: Jan-Nov 2024
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
Measured: Jan-Nov 2024
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
Measured: Jan-Nov 2024
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
Measured: Jan-Nov 2024
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
Measured: Jan-Nov 2024
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.
Measured: Jan-Nov 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lunit Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nisha Sharma, Principal investigator, The Leeds Teaching Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232070
- Sponsor's protocol ID
- Lunit INSIGHT protocol
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No patient identifiable data will be shared outside of the direct care team for the main study. The qualitative interview data will only be available to the King's College Research team which also be anonymized after transcription.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06232070
- Acronym / sponsor ID
- Lunit INSIGHT protocol
- Conditions
- Breast Cancer, Breast Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Lunit Inc.Industry (pharma, biotech, devices)
- Collaborators
- King's College London, The Leeds Teaching Hospitals NHS Trust
- Study start
- Feb 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- 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
- To assess clinician reported agreement with the Lunit INSIGHT MMG report
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Lunit INSIGHT MMGAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The symptomatic breast population will be recruited from the breast service 2 week pathway referred to a 'one-stop' breast clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lunit INSIGHT MMGIn 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 | Device | Lunit Assisted Arm |
Primary outcome
Sensitivity, specificity and cost effectiveness of Lunit INSIGHT MMG
Time frame: Jan-Nov 2024
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
Acceptability of Lunit INSIGHT MMG to patients and NHS workforce
Time frame: Jan-Nov 2024
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
Cost Effectiveness of introducing Lunit INSIGHT MMG
Time frame: Jan-Nov 2024
To assess the cost effectiveness of introducing Lunit INSIGHT MMG at the 'one-stop' breast clinic
6 secondary outcomes
Sensitivity and specificity of the Lunit INSIGHT MMG assisted single Human reading compared to double human reading
Time frame: Jan-Nov 2024
Number and proportion of non-agreement/arbitrations in the Lunit INSIGHT MMG assisted arm vs the Standard of care pathway arm
Time frame: Jan-Nov 2024
Correlation between the Lunit INSIGHT MMG abnormality score and the level of confidence of human reader 1 in the Lunit result
Time frame: Jan-Nov 2024
Correlation of reader level of concern score
Time frame: Jan-Nov 2024
Investigation of performance of the Lunit assisted arm in sub-categories of patients
Time frame: Jan-Nov 2024
Comparison of time to final report between the two arms
Time frame: Jan-Nov 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. No patient identifiable data will be shared outside of the direct care team for the main study. The qualitative interview data will only be available to the King's College Research team which also be anonymized after transcription.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Sharma principal investigator
The Leeds Teaching Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Diseases, run by Lunit Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad MS Sayeem (+44 (0) 20 784 89527, kitec@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity and cost effectiveness of Lunit INSIGHT MMG (time frame: Jan-Nov 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.