Supplemental screening for women with extremely dense breast tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.