Life sciences · Interventional Study
ClinicalTrials.gov · October 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07878377). This is a study registration, not published results. Lead sponsor: Radboud University Medical Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 2628 participants (ESTIMATED). Conditions: Breast Cancer Detection, Breast Cancer, Screening Strategy. Interventions: PROCEDURE: Breast MRI Screening; BEHAVIORAL: Questionnaires. Primary outcome measures: Cancer Detection Rate , At the time of the screening examination and through linkage with the national cancer registry during at least 1-year follow-up.; Tumor Size of MRI-Detected Breast Cancers , At breast cancer diagnosis, within 12 months after screening.; Cost per Cancer Detected , At study completion (60 months).. Brief 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.