breast cancer
Conditions
Interventions
The diagnosis of breast cancers was made by using a well-validated protocol of
our institute using an intravenous administration of iopromide (Ultravist 300,
1.5 mL/kg bodyweight). In order to study
breast cancer
contrast administration
Contrast enhanced spectral mammografie
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Female patient with histopathogically confirmed invasive breast cancer who recently underwent a clinical CESM exam without complications; 2. Treated with primary surgery; 3. Willing and able to undergo all study procedures; 4. Has personally provided written informed consent. 5. Age * 18
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Allergy for any of the ingredients of (Ultravist) contrast agent 3. Being unable to give informed consent in person 4. History of coronary arterial disease or unstable angina 5. Acute or chronic severe renal insufficiency (glomerular filtration rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All exams will be reviewed by two expert CESM radiologists, blinded for contrast dose used, final tumor pathology and extent, and each other*s results. The primary study parameter will be assessed for both the clinical and reduced CESM exam and will consist of maximum tumor diameter. Final tumor pathology results as assessed on the surgical specimen will serve as the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations. | — |
Countries
The Netherlands
Outcome results
None listed