Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636370
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Supplemental Screening for Women With Extremely Dense Breast Tissue the DENSE-2 Trial
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DENSE-2
Brief 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
Detailed Description:
Women with extremely dense breast tissue have a higher risk of developing breast cancer and at the same time mammography has limited value for these women Currently these women are not offered supplemental screening Therefore the investigators of the DENSE-2 trial will study supplemental CEM and AB-MRI screening in women with extremely dense breast tissue within the population-based breast cancer screening program because these modalities are expected to have higher diagnostic accuracy than tomosynthesis and ultrasound In addition these modalities are expected to be less expensive and require less capacity than a full MRI protocol as examined in the DENSE trial For both CEM and AB-MRI no results are currently available from a prospective screening study The DENSE-2 trial is a randomized controlled trial comparing two intervention arms CEM intervention arm A and abbreviated MRI intervention arm B each with mammography control arm C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None