At a glance
ClinicalIndex Comparison RecordN/ACompleted· 40,373 enrolled
Drug / intervention
Contrast enhanced breast MRIother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
In Brief
A clinical study evaluating Contrast enhanced breast MRI for Breast Cancer. Completed, enrolled 40,373 participants across 9 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesNetherlands
CollaboratorsDutch Breast Cancer Screening Organisations, Dutch Reference Centre for Screening, National Institute for Public Health and the Environment (RIVM), The Netherlands Cancer Institute, University Medical Center Nijmegen, Jeroen Bosch Ziekenhuis, Albert Schweitzer Hospital, Hospital Group Twente (ZGT), Amsterdam UMC, location VUmc, Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Cancer Society, Pink Ribbon Inc., A Sister's Hope, Bayer, Stichting Kankerpreventie Midden-West, Volpara Solutions
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartNov 2011
Primary CompletionApr 2023
TodayJul 2026
First PostedMar 15, 2011
Enrollment StartNov 1, 2011
Primary CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 15.3 years ago
Interventions
Contrast enhanced breast MRIother
Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.