Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM)

September 25, 2023 updated by: Jung Kyu Ryu,MD, Kyung Hee University Hospital at Gangdong

Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM): A Prospective, Multicenter Cohort Study

This prospective study aims to generate real-world evidence on the overall benefits and disadvantages of using Lunit INSIGHT MMG AI based CADe/x for breast cancer detection in a population-based breast cancer screening program in Korea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Several challenges have been identified in breast cancer screening: 1) Some breast cancer cases not identified through screening; 2) Excessive recalls for further testing; 3) Low sensitivity in dense breasts; 4) Inter-reader variability. AI-based CADe/x has been shown to improve radiologist performance and provides results equivalent or superior to those from radiologists alone.
  2. This multicenter, prospective study involves women who visit sites for breast cancer screening in Korea. Women eligible for national cancer screening in the relevant year who read the study participant recruitment brochure and read and sign the Participant Information Sheet and Informed Consent Form will be recruited into this study. Approximately 32,714 participants will be enrolled from February 2021 through December 2022 at five study sites in Korea.
  3. In Korea, a single radiologist performs mammogram readings. If recall is required (per usual care), further diagnostic work-up will be conducted to confirm cancer detected at screening. The national cancer registry databases will be reviewed in 2026 and 2027. Available findings will be recorded for all participants regardless of their screening status to identify study participants with breast cancer diagnosis within one year and within two years from screening.
  4. In primary outcome measurement, as part of the standard screening procedure, mammograms will be read and recorded by a breast radiologist without AI-CADe/x, and then with AI-based CADe/x. [Set1]
  5. In secondary outcome measurement, mammograms from the same participants as Set 1 will be read and recorded by a general radiologist without AI-based CADe/x, and then with AI-based CADe/x. [Set 2] In additional secondary outcome measurement, arbitration reading will be conducted by another breast radiologist without AI-based CADe/x for cases in which the reading results of the two radiologists without AI-based CADe/x in Set 1 and Set 2 are inconsistent. [Set 3]
  6. After completing the standard screening procedure in Set 1, several situational comparison groups [Set2 and Set3] for comparison the diagnostic accuracy will be performed independently and retrospectively The results from Set 2 and Set 3 will not impact the clinical decision(s) associated with the care of the study participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seongnam-si, Korea, Republic of
        • Department of Radiology, CHA bundang Medical Center
      • Seoul, Korea, Republic of, 04401
        • Department of Radiology, Soonchunhyang University Hospital
      • Seoul, Korea, Republic of
        • Department of Radiology, Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Department of Radiology, Kyung Hee University Hospital at Gangdong
      • Seoul, Korea, Republic of
        • Department of Radiology, Nowon Eulgi Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants of breast cancer screening in Korean women aged 40 years or older with average risk of breast cancer.

Description

Inclusion Criteria:

  • Participants must meet all of the following inclusion criteria in order to be enrolled in the study:
  • Be eligible for national cancer screening in the relevant year and visit the site for breast cancer screening
  • Provide consent for study participation using the Informed Consent Form and complete a Participant information Sheet

Exclusion Criteria:

  • Participants who meet any of the following criteria will be excluded from the study:
  • Has a history of or current breast cancer
  • Is currently pregnant or plans to become pregnant in the next 12 months
  • Has a history of breast surgery (mammoplasty or insertion of a foreign substance, such as paraffin or silicon)
  • Has mammography for diagnostic purposes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
same as study population
Use of AI-based CADe/x by breast radiologists
Device: Lunit INSIGHT MMG CADe/x for medical imaging
• A software that detects areas suspected of breast cancer using mammographic images, marks areas suspected of malignant lesions, and displays the probability of malignant lesions to assist with the interpreting physician's diagnosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• Diagnostic accuracy with difference between breast radiologists with and without AI-based CADe/x
Time Frame: 12months after screening, 24months after screening
Diagnostic accuracy is assessed using cancer registry data as the reference group to calculate cancer detection rate [CDR], recall rate, sensitivity, positive predictive value
12months after screening, 24months after screening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
• Diagnostic accuracy and difference of the following comparison groups with or without AI
Time Frame: 12months after screening, 24 months after screening
  • Between general radiologist with and without AI-based CADe/x
  • Between breast radiologist arbitration reading and breast radiologist with AI-based CADe/x
  • Between breast radiologist arbitration reading and general radiologist with AI-based CADe/x
  • Between general radiologist with AI-based CADe/x and breast radiologist without AI-based CADe/x
  • Between breast radiologist without AI-based CADe/x and stand-alone AI-based CADe/x
  • Between general radiologist without AI-based CADe/x and stand-alone AI-based CADe/x
  • Between breast radiologist with AI-based CADe/x and general radiologist with AI-based CADe/x
  • Between breast radiologist without AI-based CADe/x and general radiologist without AI-based CADe/x

Diagnostic accuracy is assessed using cancer registry data as the reference group to calculate CDR, recall rate, sensitivity, PPV, specificity, interval cancer rate, and AUROC.
12months after screening, 24 months after screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyung Hee University Hospital at Gangdong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Korea Health Industry Development Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yun-Woo Chang, MD, PhD, Soonchunhyang University Hospital, Seoul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • oddie2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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