Contrast-enhanced spectral mammography for breast cancer

Regulatory information

Senographe Pristina is a CE-marked class IIb medical device regulated under the EU medical devices directive (MDD). One Medicines and Healthcare products Regulatory Agency (MHRA) field safety notice (2019/006/006/291/001) was identified but this related to the use of the device to take biopsies, and did not affect the safety of the device for contrast-enhanced spectral mammography (CESM).

3Dimensions Mammography System is a CE-marked class IIb medical device regulated under the EU MDD. Two MHRA field safety notices were identified: one (2018/012/010/601/008) related to issues visualising contrast uptake and needed recalibration of the I‑View software. The other (2020/001/022/601/003) related to abnormal wear of components which could cause mechanical failure.

Fujifilm digital mammography system AMULET Innovality is a CE-marked class IIb medical device regulated under the EU MDD. One MHRA field safety notice was identified (2017/007/025/291/004) and related to mechanical failure.

MAMMOMAT Revelation is a CE-marked class IIb medical device regulated under the EU MDD. No MHRA field safety notices were identified.

One patient and public involvement group raised concerns relating to the long-term effects of radiation exposure associated with CESM, especially in people also exposed to radiation for treatment. In addition to the safety notices identified above, 5 studies (Avramova-Cholakova et al. 2021, Bicchierai et al. 2022, Fusco et al. 2020, James et al. 2017 and Jeukens et al. 2014), including 1,040 people, were identified that compared radiation doses between CESM and other mammography technologies (full-field digital mammography [FFDM] or digital breast tomosynthesis [DBT]). Four studies reported that the average glandular dose was higher for CESM than FFDM, which is expected as the breast undergoes a standard 2D (low-energy) exposure and a separate high-energy exposure. Two clinical experts stated that total CESM dose could be between 10% and 80% higher than FFDM, depending on the model of mammography machine and the thickness of the breast. Three studies reported the glandular dose was higher for CESM than DBT; however, 1 study reported the dose for CESM was lower. One of the experts commented that the difference between doses delivered by DBT and CESM will depend on the model of mammography machine. One study (Gennaro et al. 2022) reported a significant difference in mean glandular dose between the same model of mammography machine in 2 different centres, for low-energy images, and high-energy images. One of the experts commented that this is likely to be an issue with setup and optimisation of the machine. One expert commented that the mean glandular dose of CESM lies below NHS breast screening programme remedial level for 2D mammography and is consistent with published literature (Fusco et al. 2020; Jeukens et al. 2014). Another expert commented that CESM radiation doses were within UK and EU guidelines.