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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: AI selection for supplemental breast MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|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)|
|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|
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.
- 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
- 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
- Invasiveness [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]In situ and/or Invasive cancer
- Histology [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]Ductal, Lobular, Mucinous, Tubular, Other
- Lymph node metastasis [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]0 nodes, 1-3 nodes, 4 or more nodes
- 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
- Receptor status [ Time Frame: All diagnosed breast cancer within 27 months of study inclusion ]ER positive/negative, PR positive/negative, HER2 positive/negative
- Age [ Time Frame: At study inclusion ]Age of the woman
- Distribution of AI scores [ Time Frame: At study inclusion ]Histogram, mean, median and dispersion measures for the AI Scores
- 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
- 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
- Participant questionnaire [ Time Frame: At study inclusion ]Participant questionnaire replies for MRI contraindications and for Breast cancer-related history
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
|Contact: Fredrik Strand, MDPhDemail@example.com|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17164|
|Contact: Fredrik Strand, MD PhD +46851770000 firstname.lastname@example.org|
|Principal Investigator: Fredrik Strand, MD PhD|
|Principal Investigator:||Fredrik Strand, MDPhD||Karolinska University Hospital|