NCT01315015

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,373

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

11.4 years

First QC Date

March 14, 2011

Last Update Submit

April 24, 2025

Conditions

Breast Cancer

Keywords

Breast cancerBreast neoplasmMagnetic Resonance ImagingBreast densityEarly detection of cancerCancer screening testSecondary prevention

Outcome Measures

Primary Outcomes (1)

  • The number of interval cancers will be compared between the MRI group and the control group

    The intervention will be carried out for six years, i.e. 3 screening rounds. Given a two year recruitment period, the total study time will be 8 years.

    8 years (with an interim analysis every two years; time period between two screening rounds)

Secondary Outcomes (8)

  • The number of MRI screen-detected tumors will be determined

    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

    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

    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

    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

    6 years (with an interim analysis every two years; time period between two screening rounds)

  • +3 more secondary outcomes

Study Arms (2)

Contrast enhanced breast MRI

EXPERIMENTAL

The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.

Other: Contrast enhanced breast MRI

Regular breast cancer screening

NO INTERVENTION

No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).

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.

Also known as: MR Mammography
Contrast enhanced breast MRI

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dutch breast cancer screening participants, aged 50-75 years
  • \> 75% mammographic density
  • Negative mammographic examination (BIRADS 1 or 2)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Hospital Group Twente (ZGT)

Almelo, Netherlands

Location

Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Hospital Group Twente (ZGT)

Hengelo, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (6)

  • van Grinsven SEL, Mann RM, Monninkhof EM, Duvivier K, de Jong MDF, de Koekkoek-Doll PK, Loo CE, Pijnappel RM, van der Sluijs R, Veltman J, van Gils CH, Veldhuis WB; DENSE Trial Study Group. Multireader Diagnostic Accuracy of Abbreviated Breast MRI for Screening Women with Extremely Dense Breasts. Radiology. 2025 May;315(2):e241233. doi: 10.1148/radiol.241233.

    PMID: 40392091DERIVED

  • Verburg E, van Gils CH, van der Velden BHM, Bakker MF, Pijnappel RM, Veldhuis WB, Gilhuijs KGA. Validation of Combined Deep Learning Triaging and Computer-Aided Diagnosis in 2901 Breast MRI Examinations From the Second Screening Round of the Dense Tissue and Early Breast Neoplasm Screening Trial. Invest Radiol. 2023 Apr 1;58(4):293-298. doi: 10.1097/RLI.0000000000000934. Epub 2022 Oct 17.

    PMID: 36256783DERIVED

  • Verburg E, van Gils CH, van der Velden BHM, Bakker MF, Pijnappel RM, Veldhuis WB, Gilhuijs KGA. Deep Learning for Automated Triaging of 4581 Breast MRI Examinations from the DENSE Trial. Radiology. 2022 Jan;302(1):29-36. doi: 10.1148/radiol.2021203960. Epub 2021 Oct 5.

    PMID: 34609196DERIVED

  • Veenhuizen SGA, de Lange SV, Bakker MF, Pijnappel RM, Mann RM, Monninkhof EM, Emaus MJ, de Koekkoek-Doll PK, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, van Gils CH, Veldhuis WB; DENSE Trial Study Group. Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial. Radiology. 2021 May;299(2):278-286. doi: 10.1148/radiol.2021203633. Epub 2021 Mar 16.

    PMID: 33724062DERIVED

  • Bakker MF, de Lange SV, Pijnappel RM, Mann RM, Peeters PHM, Monninkhof EM, Emaus MJ, Loo CE, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, Veldhuis WB, van Gils CH; DENSE Trial Study Group. Supplemental MRI Screening for Women with Extremely Dense Breast Tissue. N Engl J Med. 2019 Nov 28;381(22):2091-2102. doi: 10.1056/NEJMoa1903986.

    PMID: 31774954DERIVED

  • de Lange SV, Bakker MF, Monninkhof EM, Peeters PHM, de Koekkoek-Doll PK, Mann RM, Rutten MJCM, Bisschops RHC, Veltman J, Duvivier KM, Lobbes MBI, de Koning HJ, Karssemeijer N, Pijnappel RM, Veldhuis WB, van Gils CH. Reasons for (non)participation in supplemental population-based MRI breast screening for women with extremely dense breasts. Clin Radiol. 2018 Aug;73(8):759.e1-759.e9. doi: 10.1016/j.crad.2018.04.002. Epub 2018 Jun 18.

    PMID: 29759590DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carla H van Gils, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Wouter B Veldhuis, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Epidemiology of Cancer

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

NL(9)