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

NCT04832594 | Unknown

• 1 other identifier: KSRAD001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Significantly Delayed Breast Cancer Detection per 1000 women

  Composite end-point defined by either: 1. Interval Cancer, 2. Cancer with lymph node metastasis, 3. Cancer with invasive component larger than 15 mm

  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.

Secondary Outcomes (11)

• MRI-detected breast cancer

  Diagnosis during work-up within 2 months of the initial screening MRI

• Invasiveness

  All diagnosed breast cancer within 27 months of study inclusion

• Histology

  All diagnosed breast cancer within 27 months of study inclusion

• Lymph node metastasis

  All diagnosed breast cancer within 27 months of study inclusion

• Tumor size

  All diagnosed breast cancer within 27 months of study inclusion

Study Arms (2)

Supplemental MRI

EXPERIMENTAL

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

No MRI (standard-of-care)

NO INTERVENTION

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.

Interventions

AI selection for supplemental breast MRI OTHER

An AI tool will generate scores used to determine eligibility. Women randomized to MRI will be examined in an MRI scanner.

Supplemental MRI

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete four-view screening mammography examination

You may not qualify if:

• Women in surveillance program referred from the hereditary cancer unit
• Breast implants
• Prior breast cancer
• Breast feeding
• MRI contraindication requiring radiologist assessment
• AI Tool unable to process mammograms due to technical reason

Sponsors & Collaborators

• Karolinska University Hospital: lead
• KTH Royal Institute of Technology: collaborator
• Region Stockholm: collaborator
• Bröstcancerförbundet, Sweden: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17164, Sweden

Location

Related Publications (1)

• Salim M, Liu Y, Sorkhei M, Ntoula D, Foukakis T, Fredriksson I, Wang Y, Eklund M, Azizpour H, Smith K, Strand F. AI-based selection of individuals for supplemental MRI in population-based breast cancer screening: the randomized ScreenTrustMRI trial. Nat Med. 2024 Sep;30(9):2623-2630. doi: 10.1038/s41591-024-03093-5. Epub 2024 Jul 8.

  PMID: 38977914 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fredrik Strand, MDPhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

SE (1)