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

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Trial Identification

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

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

Study ID: NCT01315015

Conditions

Breast Cancer

Study Description

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).

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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, , Netherlands

Contact Details

Name: Carla H van Gils, PhD

Affiliation: UMC Utrecht

Role: PRINCIPAL_INVESTIGATOR

Name: Wouter B Veldhuis, MD PhD

Affiliation: UMC Utrecht

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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