Performance of an Artificial Intelligence System for Breast Cancer Detection on Screening Mammograms from BreastScreen Norway.
Marthe Larsen, Camilla F Olstad, Christoph I Lee...
https://pubmed.ncbi.nlm.nih.gov/38597784Actively Recruiting
Phase Not Applicable
Age: 45Years - 69Years
FEMALE
Healthy Volunteers
ID07075679
Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI
Led by University Hospital Olomouc · Updated on 2026-04-02
8000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of artificial intelligence (AI) to assist in interpreting mammography images for breast cancer screening. The study compares a new approach where a single radiologist reads mammograms with AI support against the current standard of having two radiologists independently read the images without AI. This research aims to understand how AI might affect the quality of breast cancer screening programs. Participants are randomly assigned to one of two groups based on specific days. In the intervention group, one radiologist reviews the mammogram images with AI assistance, followed by a standard second reading by another radiologist to meet legal double-reading requirements. In the control group, two radiologists independently read the mammograms without AI support, following current standard practice. Participants are asymptomatic women aged 45 to 69 years who take part in a breast cancer screening program. The study measures outcomes such as the rate of further assessments needed within 190 days after screening, cancer detection rates up to one year after screening, and recall rates within 190 days. The study is set to start in October 2025 and will monitor these outcomes to assess the impact of AI support in mammogram reading.
CONDITIONS
Brief Title
Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)
Who Can Participate
Age: 45Years - 69Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women aged 45 to 69 years
- Asymptomatic women participating in a breast cancer screening program
You will not qualify if you...
- Presence of clinical signs of breast disease requiring diagnostic mammography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo screening mammography which is read either by one radiologist with AI support followed by a second radiologist reading, or by two radiologists without AI support according to randomization assignment.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 1 year
Participants are monitored for outcomes such as further assessment, cancer detection, and recall up to one year after the screening mammography.
Follow-up assessments as per standard screening program
Trial Site Locations
Total: 1 location
1
University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
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Research Team
L
Lucia Veverkova, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Kristina Lång, Viktoria Josefsson, Anna-Maria Larsson...
https://pubmed.ncbi.nlm.nih.gov/37541274