An interventional study of Breast MRI Screening and Questionnaires in Breast Cancer Detection, Breast Cancer and Screening Strategy, sponsored by Radboud University Medical Center. Not yet recruiting. Open to female participants aged 45 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Screening
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 2,628 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants will undergo a one-time abbreviated breast MRI examination combined with a series of questionnaires before and after screening. A subset of participants will also complete follow-up questionnaires at 1 year, and a small group will be invited for qualitative interviews. This combined approach evaluates both the diagnostic performance of MRI and the psychological impact of screening.
Procedure: Breast MRI Screening · Behavioral: Questionnaires
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.
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
Cancer Detection Rate
Number of breast cancers detected per 1,000 women screened using a single abbreviated breast MRI at age 45.
Time frame: 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
Tumor size of breast cancers detected by abbreviated breast MRI, measured in millimeters on final histopathology.
Time frame: At breast cancer diagnosis, within 12 months after screening.
Cost per Cancer Detected
Average screening-related costs per breast cancer detected through the one-time abbreviated breast MRI screening program.
Time frame: At study completion (60 months).
Histologic Grade of MRI-Detected Breast Cancers
Distribution of histologic grade (Grade 1, Grade 2, or Grade 3) among breast cancers detected by abbreviated breast MRI.
Time frame: At breast cancer diagnosis, within 12 months after screening.
Receptor Status of MRI-Detected Breast Cancers
Distribution of hormone receptor and HER2 status among breast cancers detected by abbreviated breast MRI.
Time frame: At breast cancer diagnosis, within 12 months after screening.
Nodal Status of MRI-Detected Breast Cancers
Distribution of nodal status (N0-N3) among breast cancers detected by abbreviated breast MRI.
Time frame: At breast cancer diagnosis, within 12 months after screening.
Stage Distribution of MRI-Detected Breast Cancers
Distribution of breast cancer stage (Stage 0, I, II, III, or IV) among cancers detected by abbreviated breast MRI.
Time frame: At breast cancer diagnosis, within 12 months after screening.
Participant Experience With MRI Screening
Participant-reported experience with abbreviated breast MRI screening, assessed using a standardized post-screening questionnaire and summarized as an overall experience score.
Time frame: Within 4 weeks after MRI screening.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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