Supplemental screening for women with extremely dense breast tissue
Contrast-enhanced Mammography and Abbreviated MRI as Supplemental Screening Modalities for Women Aged 50-75 With Extremely Dense Breast Tissue: the DENSE-2 Trial
This study is testing if two new screening methods, contrast-enhanced mammography and abbreviated MRI, can help women with very dense breast tissue find breast cancer earlier than regular mammograms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36000 (estimated) |
| Ages | 49 Years to 72 Years |
| Sex | Female |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06636370 on ClinicalTrials.gov |
What this trial studies
The DENSE-2 trial investigates the effectiveness of contrast-enhanced mammography (CEM) and abbreviated MRI (AB-MRI) as supplemental screening methods for women with extremely dense breast tissue, who are at a higher risk for breast cancer. This randomized controlled trial compares these two interventions against standard mammography within the Dutch population-based breast cancer screening program. The goal is to determine if these alternative screening methods can provide earlier detection of tumors while being more cost-effective and requiring less capacity than full MRI protocols. Participants will be women aged 49-72 with extremely dense breast tissue and a negative mammography result.
Who should consider this trial
Good fit: Ideal candidates are women aged 49-72 with extremely dense breast tissue who have had a negative mammography result.
Not a fit: Patients with breast implants or those who are not participants in the Dutch population-based breast cancer screening program may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of breast cancer in women with extremely dense breast tissue, potentially saving lives.
How similar studies have performed: While the DENSE trial has shown success with MRI, the use of CEM and AB-MRI as supplemental screening methods is novel and has not been extensively tested in prospective studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Carla van Gils, Prof. — UMC Utrecht
- Study coordinator: Carla van Gils, Prof
- Email: dense-2@umcutrecht.nl
- Phone: 0031-88-7568181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.