Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06636370
NA

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

Sponsor: C.H. van Gils

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

49 Years - 72 Years

Study Type

INTERVENTIONAL

Enrollment

36000

Start Date

2024-11-11

Completion Date

2031-09-01

Last Updated

2024-12-18

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Contrast-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_TEST

Abbreviated 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