Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial (NCT06636370) | Clinical Trial Compass
RecruitingNot Applicable
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
Netherlands36,000 participantsStarted 2024-11-11
Plain-language summary
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.
Who can participate
Age range
49 Years – 72 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 49-72 years (women are invited to the Dutch screening program in the year they turn 50, so the minimum age is 49 years. The maximum age for inclusion is 72 years to ensure that women can still participate in a second round of supplemental screening).
* Living in the service area (travel distance of up to 60 km) of the 15 participating hospitals.
* Absence of breast implants (Quantra cannot provide an accurate density determination for breasts with implants).
* No objection to data sharing.
* Not a participant in the DENSE trial or STREAM trial (participants in the DENSE and STREAM trials are known to the Dutch screening organization).
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):
* Presence of in-body metals (only for AB-MRI, this involves specific metals and is asked by telephone).
* Previous allergic reaction to the provided contrast agent.
* Renal insufficiency (glomerular filtration rate \<30 ml/min) (only for CEM, is checked for with questionnaire I and possibly renal function measurement).
* Severe claustrophobia (only for AB-MRI).
* Severe obesity (weight \>150 kg) (only for AB-MRI…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.