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

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ClinicalTrials.gov Identifier: NCT01315015
Recruitment Status : Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : June 8, 2021
Sponsor:
Collaborators:
Dutch 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)
VU University Medical Center
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
Information provided by (Responsible Party):
C.H. van Gils, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE March 14, 2011
First Posted Date  ICMJE March 15, 2011
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE November 2011
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
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) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
  • 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) ]
    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.
  • 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 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.
  • 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 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.
  • 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 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.
  • 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 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.
  • 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 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.
  • The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program [ Time Frame: 8 years ]
    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.
  • The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires [ Time Frame: 8 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
  • 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 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.
  • 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 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.
  • 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 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.
  • 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 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.
  • 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 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.
  • The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program [ Time Frame: 8 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
Official Title  ICMJE Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
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.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.
Other Name: MR Mammography
Study Arms  ICMJE
  • Experimental: Contrast enhanced breast MRI
    The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.
    Intervention: Other: Contrast enhanced breast MRI
  • No Intervention: Regular breast cancer screening
    No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 3, 2021)
40373
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2011)
14000
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01315015
Other Study ID Numbers  ICMJE UMCU DENSE
ZONMW-200320002-UMCU ( Other Grant/Funding Number: ZonMw )
Pink Ribbon-10074 ( Other Grant/Funding Number: Dutch Pink Ribbon / a Sister's hope )
BSP-DENSE ( Other Grant/Funding Number: Bayer HealthCare, Medical Care )
DCS-UU-2009-4348 ( Other Grant/Funding Number: Dutch Cancer Society )
DCS-UU-2014-6859 ( Other Grant/Funding Number: Dutch Cancer Society )
UMCU DENSE ( Other Grant/Funding Number: University Medical Center Utrecht )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C.H. van Gils, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE
  • Dutch 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)
  • VU University Medical Center
  • 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
Investigators  ICMJE
Principal Investigator: Carla H van Gils, PhD UMC Utrecht
Principal Investigator: Wouter B Veldhuis, MD PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP