No phaseRecruiting
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
Contrast-enhanced Mammography and Abbreviated MRI as Supplemental Screening Modalities for Women Aged 50-75 With Extremely Dense Breast Tissue: the DENSE-2 Trial
- Sponsor
- C.H. van Gils (Academic or other)
- Enrolment
- 36,000 planned
- Conditions
- Breast Cancer
- Interventions
- Contrast-enhanced mammography (CEM); Abbreviated MRI (AB-MRI)
- Ages
- adults, older adults
- Registry
- NCT06636370
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Interval Cancer Rate
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered