Breast Cancer DetectionSAFE-MRINCT07878377
Screening and the Future of Enhanced MRI for Early Breast Cancer Detection
A study testing Breast MRI Screening and Questionnaires in people with Breast Cancer Detection and Breast Cancer, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Detection, Breast Cancer, Screening Strategy
- What is being tested?
- Breast MRI Screening and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,628 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 45 years at the time of enrollment
- Resident in the Netherlands
- Able and willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Breast Cancer Detection, Breast Cancer, Screening Strategy
- Being tested
- Breast MRI Screening, Questionnaires
- Keywords
- Breast cancer screening, early detection, abbreviated MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRI ScreeningProcedure or surgery
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.
QuestionnairesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Breast MRI Screening | Experimental | 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. Receives: Procedure: Breast MRI Screening; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate
Number of breast cancers detected per 1,000 women screened using a single abbreviated breast MRI at age 45.
Measured: 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.
Measured: 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.
Measured: At study completion (60 months).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 4 weeks after MRI screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, The Netherlands Cancer Institute, Maastricht University Medical Center, University Medical Center Groningen, Ziekenhuisgroep Twente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878377
- Sponsor's protocol ID
- NL
- Acronym
- SAFE-MRI
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and the Future of Enhanced MRI for Early Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT07878377
- Acronym / sponsor ID
- SAFE-MRI / NL
- Conditions
- Breast Cancer Detection, Breast Cancer, Screening Strategy
- Keywords
- Breast cancer screening, early detection, abbreviated MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,628 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, The Netherlands Cancer Institute, Maastricht University Medical Center, University Medical Center Groningen, Ziekenhuisgroep Twente
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast MRI Screening | Experimental | Procedure: Breast MRI Screening, Behavioral: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 45 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 45 years at the time of enrollment
- Resident in the Netherlands
- Able and willing to provide informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast MRI ScreeningParticipants 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. | Procedure or surgery | Breast MRI Screening |
| QuestionnairesPre-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 | Behavioural | Breast MRI Screening |
Primary outcome
Cancer Detection Rate
Time frame: At the time of the screening examination and through linkage with the national cancer registry during at least 1-year follow-up.
Number of breast cancers detected per 1,000 women screened using a single abbreviated breast MRI at age 45.
Tumor Size of MRI-Detected Breast Cancers
Time frame: At breast cancer diagnosis, within 12 months after screening.
Tumor size of breast cancers detected by abbreviated breast MRI, measured in millimeters on final histopathology.
Cost per Cancer Detected
Time frame: At study completion (60 months).
Average screening-related costs per breast cancer detected through the one-time abbreviated breast MRI screening program.
5 secondary outcomes
Histologic Grade of MRI-Detected Breast Cancers
Time frame: At breast cancer diagnosis, within 12 months after screening.
Receptor Status of MRI-Detected Breast Cancers
Time frame: At breast cancer diagnosis, within 12 months after screening.
Nodal Status of MRI-Detected Breast Cancers
Time frame: At breast cancer diagnosis, within 12 months after screening.
Stage Distribution of MRI-Detected Breast Cancers
Time frame: At breast cancer diagnosis, within 12 months after screening.
Participant Experience With MRI Screening
Time frame: Within 4 weeks after MRI screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Breast MRI Screening and Questionnaires in people with Breast Cancer Detection and Breast Cancer, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ritse Mann, Dr. (0031243614546, Ritse.Mann@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection Rate (time frame: At the time of the screening examination and through linkage with the national cancer registry during at least 1-year follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.