Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using AI to Select Women for Supplemental MRI in Breast Cancer Screening (ScreenTrustMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832594
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
KTH Royal Institute of Technology
Region Stockholm
Bröstcancerförbundet, Sweden
Information provided by (Responsible Party):
Fredrik Strand, Karolinska University Hospital

Brief Summary:
This is a prospective clinical trial aiming to determine the ability of an AI pipeline to identify women who would benefit from supplemental MRI in terms of decreasing the number of cancers having a significantly delayed detection

Condition or disease Intervention/treatment Phase
Breast Cancer Other: AI selection for supplemental breast MRI Not Applicable

Detailed Description:

All women attending mammography screening at Karolinska University Hospital will have their mammograms analyzed by AI (Figure 1). The specific AI-implementation (AI tool) in this study is a result of AI predictions from three equally weighted component AI models analyzing mammograms: (i) masking predictor, (ii) risk predictor and (iii) cancer signs predictor (by one commercial CAD model and one in-house academic CAD model); the age of the woman is also taken into account by multiplying the score with (110-age)/70. The purpose of the age factor is to attain a relatively similar proportion of MRI exams in the lower and higher age groups. The aim of the AI tool is to identify women with the highest probability of having a delay in cancer detection, i.e., having had a false negative screening mammogram.

The specific AI tool and its settings will remain the same during the study. For each examination, the AI tool will produce an AI Joint Score and an AI Masking Score. Women having an AI Masking Score above the threshold and an AI Joint Score above the threshold will be invited to the study unless they met exclusion criteria. Women who decide to participate, will be randomized to MRI or no-MRI (standard-of-care).

A Signa Premier 3T MRI scanner from GE Healthcare will be used. The MRI protocol will contain a T2-weighted Dixon sequence and a T1-weighted dynamic contrast enhanced series, and will remain the same through the course of the study. All MRI exams will be assessed by two radiologists, where the second reader will have access to the assessment of the first reader. In case of disagreement, a consensus discussion between two radiologists will be held. The MRI exams will be assessed according to BI-RADS, and follow-up will depend on the BI-RADS category (Figure 2). Women with BI-RADS 1-2 will have no further diagnostics and will be sent a 'healthy letter'. Women with BI-RADS 3 to 5 will be recalled for 2nd look ultrasound. Women with BI-RADS 4-5 will be included in the regular process for established cancer suspicion and be discussed in a multidisciplinary team conference. For women with BI-RADS 3, the follow-up will be handled within the breast radiology unit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For each screening mammography examination, the AI tool will produce an AI Joint Score and an AI Masking Score. Women having an AI Masking Score above the threshold and an AI Joint Score above the threshold will be invited to the study unless they met exclusion criteria. Women who decide to participate, will be randomized to MRI or no-MRI (standard-of-care).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Image Analysis With Artificial Intelligence to Increase Precision in Breast Cancer Screening - the ScreenTrust MRI Substudy: a Prospective Trial of AI to Select Women for Supplemental Screening MRI
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Supplemental MRI
Women randomized to MRI will be examined using a shortened MRI protocol on a Signa Premier 3T MRI scanner. The MRI examination will be reviewed by two radiologists and assigned BI-RADS score. Appropriate clinical work-up will follow according to the BI-RADS score. BI-RADS 3 or higher at initial MRI will be recalled for a second look ultrasound.
Other: AI selection for supplemental breast MRI
An AI tool will generate scores used to determine eligibility. Women randomized to MRI will be examined in an MRI scanner.

No Intervention: No MRI (standard-of-care)
Standard-of-care. Both arms will have had a regular screening mammography examination prior to randomization. The "No MRI" arm will have no further intervention.



Primary Outcome Measures :
  1. Significantly Delayed Breast Cancer Detection per 1000 women [ Time Frame: Until 27 months from study inclusion (includes cancer detected at subsequent screening within this time frame). Cancer detected at the initial screening mammography or MRI shall not be included. ]
    Composite end-point defined by either: 1. Interval Cancer, 2. Cancer with lymph node metastasis, 3. Cancer with invasive component larger than 15 mm


Secondary Outcome Measures :
  1. MRI-detected breast cancer [ Time Frame: Diagnosis during work-up within 2 months of the initial screening MRI ]
    Breast cancer detected at the initial screening MRI for women in the Intervention arm of the study

  2. Invasiveness [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]
    In situ and/or Invasive cancer

  3. Histology [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]
    Ductal, Lobular, Mucinous, Tubular, Other

  4. Lymph node metastasis [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]
    0 nodes, 1-3 nodes, 4 or more nodes

  5. Tumor size [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]
    Size (in millimetre) for the invasive and the in situ component

  6. Receptor status [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]
    ER positive/negative, PR positive/negative, HER2 positive/negative

  7. Age [ Time Frame: At study inclusion ]
    Age of the woman

  8. Distribution of AI scores [ Time Frame: At study inclusion ]
    Histogram, mean, median and dispersion measures for the AI Scores

  9. BI-RADS codes [ Time Frame: At study inclusion and until end of 27 month follow-up ]
    For each MRI examination, the BI-RADS code for fibroglandular volume, background enhancement and breast lesions

  10. Biopsy result [ Time Frame: Diagnosis during work-up within 2 months of the MRI examination ]
    Pathology assessment of biopsy: normal tissue, benign lesion, cancer in situ, invasive cancer

  11. Participant questionnaire [ Time Frame: At study inclusion ]
    Participant questionnaire replies for MRI contraindications and for Breast cancer-related history



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete four-view screening mammography examination

Exclusion Criteria:

  • Women in surveillance program referred from the hereditary cancer unit
  • Breast implants
  • Prior breast cancer
  • Breast feeding
  • MRI contraindication requiring radiologist assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832594


Contacts
Layout table for location contacts
Contact: Fredrik Strand, MDPhD +46709795511 fredrik.strand@sll.se

Locations
Layout table for location information
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17164
Contact: Fredrik Strand, MD PhD    +46851770000    fredrik.strand@ki.se   
Principal Investigator: Fredrik Strand, MD PhD         
Sponsors and Collaborators
Karolinska University Hospital
KTH Royal Institute of Technology
Region Stockholm
Bröstcancerförbundet, Sweden
Investigators
Layout table for investigator information
Principal Investigator: Fredrik Strand, MDPhD Karolinska University Hospital
  Study Documents (Full-Text)

Documents provided by Fredrik Strand, Karolinska University Hospital:
Layout table for additonal information
Responsible Party: Fredrik Strand, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04832594    
Other Study ID Numbers: KSRAD001
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final trial dataset will be available for the research team of the principal investigator. Pseudonymized data can be made available for external research audit. Anonymous data may be shared with academic researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Available during study time and until 2 years after publication of any manuscript resulting from the study
Access Criteria: Data Transfer Agreement must be signed. Request must be made by an academic researcher at an internationally recognized university.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fredrik Strand, Karolinska University Hospital:
Artificial Intelligence
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases