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Mammography Screening With Artificial Intelligence (MASAI)

NCT04838756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2026-04-02

No results posted yet for this study

Summary

The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).

Conditions

Interventions

OTHER

AI screening modality

Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives.

OTHER

Conventional screening modality

Screen exams will be read by two radiologists without the support of AI.

Sponsors & Collaborators

  • Unilabs

    collaborator UNKNOWN

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • Region Skane

    lead OTHER

Principal Investigators

  • Kristina Lång, MD PhD · Region Skåne

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2024-12-07
Completion
2025-08-12

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838756 on ClinicalTrials.gov