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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01315015
• Other study ID #: UMCU DENSE
• Secondary ID: ZONMW-200320002-
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2011
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40373
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	's-Hertogenbosch
Netherlands	Hospital Group Twente (ZGT)	Almelo
Netherlands	Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	Hospital Group Twente (ZGT)	Hengelo
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (18)

Lead Sponsor

Collaborator

UMC Utrecht

A Sister's Hope, Albert Schweitzer Hospital, Amsterdam UMC, location VUmc, Bayer, Dutch Breast Cancer Screening Organisations, Dutch Cancer Society, Dutch Reference Centre for Screening, Hospital Group Twente (ZGT), Jeroen Bosch Ziekenhuis, Maastricht University Medical Center, National Institute for Public Health and the Environment (RIVM), Pink Ribbon Inc., Stichting Kankerpreventie Midden-West, The Netherlands Cancer Institute, University Medical Center Nijmegen, Volpara Solutions, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of MRI screen-detected tumors will be determined	The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.	6 years (with an interim analysis every two years; time period between two screening rounds)
Secondary	Tumor size, stage and grade distributions, including their histological and molecular subtypes, diagnosed in both study groups will be compared	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	The referral rate in the MRI study group will be determined	The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.	6 years (with an interim analysis every two years; time period between two screening rounds)
Secondary	The positive predictive value (and the amount of false-positive diagnoses) of MRI will be determined using the histological diagnosis as the reference test	The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.	6 years (with an interim analysis every two years; time period between two screening rounds)
Secondary	The number of biopsies per positive MRI will be determined	The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.	6 years (with an interim analysis every two years; time period between two screening rounds)
Secondary	The mortality rate in the MRI group will be compared with the control group using the MISCAN computer simulation program	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
Secondary	The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program	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
Secondary	The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires	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

External Links

•   Click here for more information about this study (website in Dutch language).