NCT06636370 Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
| NCT ID | NCT06636370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | C.H. van Gils |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36,000 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36,000 participants in total. It began in 2024-11-11 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Carla van Gils, Prof.
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT06636370 clinical trial?
This trial is open to female participants only, aged 49 Years or older, up to 72 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06636370 currently recruiting?
Yes, NCT06636370 is actively recruiting participants. Contact the research team at dense-2@umcutrecht.nl for enrollment information.
Where is the NCT06636370 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT06636370 clinical trial?
NCT06636370 is sponsored by C.H. van Gils. The principal investigator is Carla van Gils, Prof. at UMC Utrecht. The trial plans to enroll 36,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.