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DENSE Trial demonstrates huge reduction of breast cancer false positives

Ralph Highnam — CEO of Volpara Health – Published on March 29, 2021

Second round results of supplemental MRI screening for women with extremely dense breasts

The first round of screening in the Dense Tissue and Early Breast Neoplasm Screening (DENSE) Trial successfully demonstrated the use of Volpara’s TruDensity® algorithm in identifying women with extremely high breast density eligible for supplemental MRI screening. The resulting reduction in interval cancers led the Dutch government to approve the addition of MRI exams for women with extremely dense breasts to the national screening program. 

Now, the results of the trial’s second round of screening have been published, suggesting the screening program’s potential for cost-reductions and lower patient anxiety. 

In the paper published on March 16, 2021 titled “Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial,” 4,783 women were randomly selected for MRI screening from a pool of patients with extremely dense breasts (as identified by Volpara TruDensity) who had recently received a negative mammography result. Of these women, 3,436 also participated in another round of MRI screening. The results are as follows: 

  DENSE Trial round one screening  DENSE Trial round two screening 
Additional cancer detection rate (CDR)  16.5 per 1000 exams  5.8 per 1000 exams 
False-positive rate (FPR)  79.8 per 1000 exams  26.3 per 1000 exams 

 The CDR was expected to drop as a larger pool of prevalent breast cancers that cannot be detected with mammography was identified during the trial’s first round.  

It was also excepted that the FPR would drop as well. This huge reduction in false-positives during the trial’s second screening round consequently reduced unnecessary work-up and biopsies during follow-upthus maintaining the potential to positively impact both cost and patient care with this new screening protocol. 

Study authors have yet to calculate the number of interval cancers prevented during the second stage of the trialThe combination of the dramatic reduction of interval cancers in the first round and the big reduction of the FPR in the second is promising news for the feasibility of using Volpara’s TruDensity to identify candidates for supplemental MRI screening.

To learn more about Volpara’s TruDensity algorithm and how it provides an objective, continuous measure of breast density, reach out to