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

UMC Utrecht

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Contrast enhanced breast MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01315015

UMCU DENSE (Other Grant/Funding Number)

ZONMW-200320002-UMCU (Other Grant/Funding Number)

BSP-DENSE (Other Grant/Funding Number)

DCS-UU-2009-4348 (Other Grant/Funding Number)

DCS-UU-2014-6859 (Other Grant/Funding Number)

Pink Ribbon-10074 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).

Enrollment: 40,373 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40,373 participants in 2 patient groups

Contrast enhanced breast MRI

Experimental group

Description:

The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.

Treatment:

Other: Contrast enhanced breast MRI

Regular breast cancer screening

No Intervention group

Description:

No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).