The DENSE trial (Dense Tissue and Early Breast Neoplasm Screening) is an ongoing study designed to help define the role of breast MRI in screening women with dense breast tissue. In an article published in the May issue of Radiology, the authors present findings from the second phase of the trial. ^[1]Veenhuizen, SGA, de Lange, SV, Bakker, MF, et al. Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial. Radiology. … Continue reading

Based in the Netherlands, the study enrolled over 4000 women at average risk for breast cancer, who were identified as having extremely dense breast tissue following a negative screening mammography. Participants underwent breast MRI as an adjunct, and the cancer detection rate was determined.

Findings from the first phase of the trial, published in 2019, showed that supplemental screening with MRI led to a cancer detection rate (CDR) of 16.5 per 1000 screening examinations, with a false-positive rate (FPR) of 79.8 per 1000 screening examinations. Of the 79 cancers identified, 15 were DCIS; the remaining were invasive cancers. 72 of 79 were early-stage tumors (stage 0-1), and 70 were node-negative.

All participants who did not have a cancer diagnosis were offered a second screening MRI at 2 years. In this group, the cancer detection rate was 5.8 per 1000 screening examinations, with a false-positive rate of 26.3 per 1000 screening examinations (95% CI, 21.5-32.3). All tumors identified in the second round were stage 0-1 and were node-negative.

No conclusions were drawn, but the study is expected to continue at least through 2023 with a third round of screening studies.  While the impact of enhanced screening on breast cancer mortality is not a direct endpoint of the trial, the authors anticipate that the study will allow for predictive modeling in the population being studied.

While the appropriate use of breast MRI in average risk women is controversial, it should be encouraging to note that the USPSTF has published its final research plan in preparation for updating its breast cancer screening recommendations.^[2]United Services Preventive Services Taskforce, Final Research Plan: Screening for Breast Cancer, May 6, … Continue reading
As previously reported, in 2016 the task force found insufficient evidence to support breast MRI as an adjunct for screening in women with dense breasts. Carelon will continue to monitor the progress on this and other emerging evidence in this realm.

For more information on the USPSTF process, please visit: https://www.uspreventiveservicestaskforce.org/uspstf/draft-update-summary/breast-cancer-screening1