Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Contrast enhanced breast MRI

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

Group Type EXPERIMENTAL

Contrast enhanced breast MRI

Intervention Type OTHER

Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.

Regular breast cancer screening

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Contrast enhanced breast MRI

Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.

Intervention Type OTHER

Other Intervention Names

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MR Mammography

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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C.H. van Gils

Professor of Clinical Epidemiology of Cancer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carla H van Gils, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Wouter B Veldhuis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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Jeroen Bosch Hospital

's-Hertogenbosch, , Netherlands

Site Status

Hospital Group Twente (ZGT)

Almelo, , Netherlands

Site Status

Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Site Status

VU University Medical Center

Amsterdam, , Netherlands

Site Status

Albert Schweitzer Hospital

Dordrecht, , Netherlands

Site Status

Hospital Group Twente (ZGT)

Hengelo, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status

UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 40392091 (View on PubMed)

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.

Reference Type DERIVED

PMID: 36256783 (View on PubMed)

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.

Reference Type DERIVED

PMID: 34609196 (View on PubMed)

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.

Reference Type DERIVED

PMID: 33724062 (View on PubMed)

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.

Reference Type DERIVED

PMID: 31774954 (View on PubMed)

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.

Reference Type DERIVED

PMID: 29759590 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Study protocol

View Document