CompletedNot Applicable

Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

Netherlands40,373 participantsStarted 2011-11

Plain-language summary

The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show \> 75% mammographic density.

Who can participate

Age range50 Years – 75 Years

SexFEMALE

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: * Dutch breast cancer screening participants, aged 50-75 years * \> 75% mammographic density * Negative mammographic examination (BIRADS 1 or 2) Exclusion Criteria: Contraindications for MRI * The presence of intracorporeal metals * Adverse reaction to a (gadolinium-based) contrast agent in the past * Severely impaired renal function (GFR \< 40 mL/min) * Pregnant or lactating women * Claustrophobia * Adiposity (\> 150 kg)

What they're measuring

The number of interval cancers will be compared between the MRI group and the control group

Timeframe: 8 years (with an interim analysis every two years; time period between two screening rounds)

Trial details

NCT IDNCT01315015

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04

View on ClinicalTrials.gov More Breast Cancer trials