Actively Recruiting
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
Led by C.H. van Gils · Updated on 2026-05-11
36000
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
Sponsors
C
C.H. van Gils
Lead Sponsor
U
University Medical Center Groningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant in the Dutch population-based breast cancer screening program with a negative mammography result (BI-RADS classification 1 or 2)
- Extremely dense breast tissue (assessed with Quantra software, category D)
- Age between 49 and 72 years
- Living in the service area (travel distance up to 60 km) of the 15 participating hospitals
- No breast implants
- No objection to data sharing
- Not a participant in the DENSE trial or STREAM trial
You will not qualify if you...
- Presence of in-body metals (only for AB-MRI)
- Previous allergic reaction to the provided contrast agent
- Renal insufficiency (glomerular filtration rate <30 ml/min) (only for CEM)
- Severe claustrophobia (only for AB-MRI)
- Severe obesity (weight >150 kg) (only for AB-MRI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
C
Carla van Gils, Prof
CONTACT
E
Evelyn Monninkhof, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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