Dual-layer spectral computerized tomography for breast cancer detection in women with dense breasts: a single centre, feasibility study.

Breast cancer is one the most commonly diagnosed cancers among women with an
incidence rate of 89.7 per 100.000 women in Western Europe. The decline in the
mortality rate of the last few decades is mainly contributable to the great
developments both at the diagnostic and therapeutic field. However, breast
cancer still is responsible for more than 500.000 deaths annually and therefore
it remains the leading cause of cancer-related mortality worldwide.
Mammographic dense breast tissue is recognized as a major independent absolute
risk factor for the development of breast cancer, which is present in about 50%
of women over the age of 40 years. Breast cancer can be easily missed at the
routinely screening mammography due to the masking effect of dense breast
tissue in these patients. Therefore, supplemental screening with other
modalities, for example digital breast tomosynthesis (DBT), ultrasound,
magnetic resonance imaging (MRI) and cone-beam breast computed tomography
(CBBCT) has been recommended. Unfortunately, none of these modalities have
proven to be superior. The last few years dual-layer spectral computerized
tomography (DLSCT) systems have emerged to be a hot topic. This is mainly due
to lower radiation exposure and contrast agent usage. Moreover, material
decomposition images and iodine quantification analysis can be derived.
Thereby, DLSCT could be a promising screening tool which eliminates the
challenges accompanied with screening women at high-risk for breast cancer due
to dense breast tissue.

The main objective of this project is to demonstrate the feasibility of DLSCT
to detect breast cancer in women with dense breasts.

This is a prospective, single centre, case series with 14 patients who will
undergo a DLSCT scan.

Participants will be asked to undergo a contrast enhanced DLSCT scan. Since the
DLSCT scan will be performed immediately after the regular performed PET-CT
scan, there will be no need for an additional visit to the hospital. In
addition, the same intravenous access will be used for the administration of
18F-FDG and the contrast agent to minimize participant burden.
Participation in this study is associated with two potential risks. First, the
administration of contrast agents can lead to adverse reactions. The majority
are self-limited and predominantly involve dermatologic manifestations.
Besides, our team of physicians are trained to treat potential life-threatening
reactions as efficiently as possible according to local guidelines.
The second risk is related to the radiation exposure. The effective dose of
each DLSCT scan will be about 2 mSv. This is classified as low risk (category
IIb) which is justified because the research is directly aimed to prevent or
cure disease (ICRP publication 62).