RecruitingNot ApplicableNCT06636370

Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial

Contrast-enhanced Mammography and Abbreviated MRI as Supplemental Screening Modalities for Women Aged 50-75 With Extremely Dense Breast Tissue: the DENSE-2 Trial


Sponsor

C.H. van Gils

Enrollment

36,000 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 49 YearsMax Age: 72 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether women with very dense breast tissue (which can hide cancer on a mammogram) benefit from additional imaging — such as MRI or a specialized mammogram — after getting a normal result on a standard screening mammogram. You may be eligible if: you are a woman between 49 and 72 years old; you participate in the Dutch national breast screening program and recently got a normal mammogram result; you have extremely dense breast tissue; you live within 60 km of a participating hospital; and you do not have breast implants. You may NOT be eligible if: you have certain metal implants in your body (for MRI); you have had an allergic reaction to imaging contrast dye; your kidneys are not working well enough; you have severe claustrophobia; or you weigh more than 150 kg. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTContrast-enhanced mammography (CEM)

This intervention group receives supplemental screening with CEM after a negative screening result within the Dutch National Breast Cancer Screening program

DIAGNOSTIC_TESTAbbreviated MRI (AB-MRI)

This intervention group receives supplemental screening with AB-MRI after a negative screening result within the Dutch National Breast Cancer Screening program


Locations(1)

UMC Utrecht

Utrecht, Netherlands

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NCT06636370


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