Comparison of Two Imaging Methods for Suspected Breast Cancer: Low-Dose-Radiation Breast Computed Tomography versus Magnetic Resonance Imaging

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. As part of breast cancer diagnostics, bilateral mammography and ultrasound examinations are used as standard procedures. Magnetic resonance imaging (MRI) is performed only if these conventional methods do not yield clear results. The company Advanced Breast-CT GmbH has developed a new imaging method that could represent a new alternative in the diagnosis of breast cancer. The so-called low-dose breast CT is a computed tomography (CT) scan that provides a 3D image of breast tissue and involves a low radiation dose. The radiation exposure is comparable to that of an X-ray mammogram, and the examination is performed using a contrast agent.

The aim of this study is to compare the accuracy of low-dose breast CT with that of established MRI imaging. All patients will undergo both an MRI and a low-dose breast CT, preferably on the same day or within one week. Three independent radiologists will evaluate the images. The primary endpoint is whether low-dose breast CT is at least as effective (“no worse”) as MRI in detecting breast lesions. Additionally, questionnaires will be used to assess how comfortable or burdensome the examinations are perceived to be. The study is prospective and is being conducted at several hospitals in Germany and the Netherlands.

Women aged 18 and older who require an MRI due to inconclusive findings on mammography or ultrasound—whether prior to surgery, for follow-up after breast-conserving therapy, or due to an increased genetic risk—are eligible to participate. Patients with specific concerns, such as unclear breast implants or bloody discharge from the nipple, may also participate. Exclusion criteria include pregnancy or breastfeeding, a known BRCA1/2 mutation, impaired kidney or thyroid function, allergies to contrast agents, metal or magnetic implants in the breast, or severe claustrophobia.