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Screening and the Future of Enhanced MRI for Early Breast Cancer Detection
Sponsor: Radboud University Medical Center
Summary
This study aims to recruit women aged 45 years in the Netherlands to participate in a one-time breast MRI screening examination and to evaluate their motivation for participation as well as the impact of screening on their wellbeing. Recruitment will occur through public media announcements and distribution of flyers in the geeral practitioners' waiting rooms, ensuring equity and adherence to GDPR regulations. Participants will be enrolled on a first-come, first-served basis, with calls repeated every six months over an estimated three-year period. All participants will complete questionnaires assessing reasons for participation, cancer-related worry, and experiences with the screening. Outcomes will be stratified by screening result: negative, false positive, or cancer detected. A subset of women will be contacted one year later to assess long-term effects on health beliefs. Additionally, qualitative in-depth interviews will be conducted with a subgroup of participants to explore themes related to motivation and perceived impact of participation.
Key Details
Gender
FEMALE
Age Range
45 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
2628
Start Date
2027-01-01
Completion Date
2031-12
Last Updated
2026-10-16
Healthy Volunteers
Yes
Interventions
Breast MRI Screening
Participants will undergo a one-time, high-resolution breast MRI scan (\~8 minutes) including: T1-weighted acquisition before and after contrast administration Ultrafast dynamic sequences Diffusion-weighted imaging (DWI) All scans will be read by experienced breast radiologists using a high-specificity protocol. Any follow-up imaging or procedures will occur in routine clinical care.
Questionnaires
Pre-screening questionnaires: Reasons for participation, cancer-related worry, source of study awareness Post-screening questionnaires: Experience during MRI, perceived reassurance or burden, short-term wellbeing Follow-up questionnaire (1 year): Health beliefs and psychological impact (subset of participants) Qualitative interviews: Conducted with 20-30 participants from different screening outcome groups (negative, false positive, cancer detected) to explore motivations, expectations, and long-term effects