An interventional study of Contrast-enhanced mammography (CEM) and Abbreviated MRI (AB-MRI) in Breast Cancer, sponsored by C.H. van Gils. Recruiting at 1 site in Netherlands. Open to female participants aged 49 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by C.H. van Gils · Not applicable, Interventional, and Screening
Women with extremely dense breasts (nearly all glandular and connective tissue, little fatty tissue) have a 3-6 times higher risk of breast cancer than women with very low breast density. Moreover, due to the masking effect of the dense tissue, any breast tumours present are more difficult to detect in these women. With the results of the DENSE trial, the investigators showed that among women with extremely dense breasts, a combination of MRI and mammography could detect tumours earlier than mammography only. As the implementation of MRI in the screening program induces considerable costs and capacity requirements, the Dutch Ministry of Health would like to investigate whether cheaper and acceptable alternatives can be implemented more easily. In the DENSE-2 study, proposed here, we will investigate contrast-enhanced mammography and an abbreviated form of MRI as alternatives, in a large-scale randomized trial, within the current population-based screening program.
Women with extremely dense breast tissue have a higher risk of developing breast cancer and at the same time, mammography has limited value for these women. Currently, these women are not offered supplemental screening. Therefore, the investigators of the DENSE-2 trial will study supplemental CEM and AB-MRI screening in women with extremely dense breast tissue within the population-based breast cancer screening program because these modalities are expected to have higher diagnostic accuracy than tomosynthesis and ultrasound. In addition, these modalities are expected to be less expensive and require less capacity than a full MRI protocol as examined in the DENSE trial. For both CEM and AB-MRI, no results are currently available from a prospective screening study. The DENSE-2 trial is a randomized controlled trial comparing two intervention arms (CEM [intervention arm A] and abbreviated MRI [intervention arm B]) each with mammography [control arm C].
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 36,000 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with C.H. van Gils as lead sponsor.
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Exclusion Criteria:
The additional exclusion criteria for the intervention arms are checked after randomization and recruitment (this order is due to the pre-randomization design):
This group receives biennial mammography only within the current Dutch National Breast Cancer Screening program. This group will not be informed about the study (pre-randomisation design)
This group receives supplemental screening with CEM after a negative mammography result in the Dutch National Breast Cancer screening program
Diagnostic Test: Contrast-enhanced mammography (CEM)
This group receives supplemental screening with AB-MRI after a negative mammography result in the Dutch National Breast Cancer Screening program
Diagnostic Test: Abbreviated MRI (AB-MRI)
This intervention group receives supplemental screening with CEM after a negative screening result within the Dutch National Breast Cancer Screening program
This intervention group receives supplemental screening with AB-MRI after a negative screening result within the Dutch National Breast Cancer Screening program
Interval Cancer Rate
Measured as a breast cancer diagnosed in between two screening rounds
Time frame: 0 - 3 year
Advanced Cancer detectio Advanced Cancer rate
Advanced cancer is defined as TNM stage II or higher
Time frame: 0 - 3 year
Cancer detection rate
The number of breast cancers detected by CEM or AB-MRI
Time frame: 0 - 3 year
False positive rate
The number with a false positive result after CEM or AB-MRI
Time frame: 0-5 year
Participant experience with CEM - 1
screen-specific item questionnaire (SSI)
Time frame: 0-5 year
Participant experience with CEM - 2
Self-developed questionnaire
Time frame: 0-5 year
Participant experience with CEM - 3
Focus group interviews
Time frame: 0-5 year
Participant experience with AB-MRI - 1
screen-specific item questionnaire (SSI)
Time frame: 0-5 year
Participant experience with AB-MRI - 2
Self-developed questionnaire
Time frame: 0-5 year
Participant experience with AB-MRI - 3
Focus group interviews
Time frame: 0-5 year
Health-professional experience with CEM
Self-developed questionnaire
Time frame: 0-5 year
Health-professional experience with AB-MRI
Self-developed questionnaire
Time frame: 0-5 year
Estimated rate of overdiagnosis
Simulation with the MISCAN software
Time frame: 0-5 years
Cost-effectiveness
Simulation with the MISCAN software
Time frame: 0-5 year
Breast tumor size
mm
Time frame: 0-5 years
Breast tumor stage
TNM classification
Time frame: 0-5 years
Positive Predictive Value (PPV)
Using the histological diagnosis as the reference test
Time frame: 0-5 year
Biopsy rate
Per 1000 women screened with one of the modalities
Time frame: 0-5 year
Referral rate
Per 1000 women screened per screening modality
Time frame: 0-5 years
Mortality rate
Simulation with MISCAN software
Time frame: 0-5 year
Plan to share: Undecided
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