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NCT07878377
Screening and the Future of Enhanced MRI for Early Breast Cancer Detection
Conditions: Breast Cancer Detection, Breast Cancer, Screening Strategy
Sex: Female
Ages: 45 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 2628
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.
Eligibility Criteria
Inclusion Criteria:
* Women aged 45 years at the time of enrollment
* Resident in the Netherlands
* Able and willing to provide informed consent
Exclusion Criteria:
* Current pregnancy or breastfeeding
* Known renal disease with estimated glomerular filtration rate (eGFR) \< 60
* Severe claustrophobia
* Contraindication for breast MRI (e.g., pacemakers or neurostimulators)
* Contraindication for intravenous contrast administration (e.g., previous allergic reaction to contrast agent)
* Lifetime breast cancer risk ≥ 20% according to CanRisk evaluation
Source: ClinicalTrials.gov (NCT07878377). StuddyBuddy aggregates publicly available trial information.