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

Breast Cancer

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

Inclusion Criteria7

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 Criteria5

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).

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