No phaseNot yet recruiting

Screening and the Future of Enhanced MRI for Early Breast Cancer Detection (SAFE-MRI)

Sponsor
Radboud University Medical Center (Academic or other)
Enrollment
2,628 planned
Conditions
Breast Cancer Detection; Breast Cancer; Screening Strategy
Interventions
Breast MRI Screening; Questionnaires
Ages
adults
Registry
NCT07878377

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Cancer Detection Rate
  • Tumor Size of MRI-Detected Breast Cancers
  • Cost per Cancer Detected

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Registered