Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment contrast enhanced breast mri
Phase phase 4
Sponsor UMC Utrecht
Collaborator Dutch Breast Cancer Screening Organisations
Start date November 2011
End date December 2019
Trial size 36185 participants
Trial identifier NCT01315015, BSP-DENSE, DCS-UU-2009-4348, DCS-UU-2014-6859, Pink Ribbon-10074, UMCU DENSE, ZONMW-200320002-UMCU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.
contrast enhanced breast mri MR Mammography
Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.
(No Intervention)
No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).

Primary Outcomes

Measure
The number of interval cancers will be compared between the MRI group and the control group
time frame: 8 years (with an interim analysis every two years; time period between two screening rounds)

Secondary Outcomes

Measure
The number of MRI screen-detected tumors will be determined
time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
Tumor size, stage and grade distributions, including their histological and molecular subtypes, diagnosed in both study groups will be compared
time frame: 8 years (with an interim analysis every two years; time period between two screening rounds)
The referral rate in the MRI study group will be determined
time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
The positive predictive value (and the amount of false-positive diagnoses) of MRI will be determined using the histological diagnosis as the reference test
time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
The number of biopsies per positive MRI will be determined
time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
The mortality rate in the MRI group will be compared with the control group using the MISCAN computer simulation program
time frame: 8 years
The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program
time frame: 8 years
The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires
time frame: 8 years

Eligibility Criteria

Female participants from 49 years up to 75 years old.

Inclusion Criteria: - Dutch breast cancer screening participants, aged 50-75 years - > 75% mammographic density - Negative mammographic examination (BIRADS 1 or 2) Exclusion Criteria: Contraindications for MRI - The presence of intracorporeal metals - Adverse reaction to a (gadolinium-based) contrast agent in the past - Severely impaired renal function (GFR < 40 mL/min) - Pregnant or lactating women - Claustrophobia - Adiposity (> 150 kg)

Additional Information

Official title Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
Principal investigator Carla H van Gils, PhD
Description Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by UMC Utrecht.