breast carcinoma breast cancer
Conditions
Interventions
No new drug or therapeutic intervention will be investigated. Instead, a modification of an existing diagnostic procedure will be evaluated. The investigated “product/intervention” is contrast-enhance
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female sex at birth18 years or olderRecalled from the national breast cancer screening program due to suspicious findingsAble to provide informed consent
Exclusion criteria
Exclusion criteria: Patients indicated to undergo contrast-enhanced biopsy. These biopsies are excluded because they require an additional contrast volume. Inclusion in the study would therefore result in three contrast administrations in total.Contraindications for CEM, for example impaired renal function or known hypersensitivity reactions to iodinated contrast.Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be diagnostic accuracy for breast cancer detection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be qualitative lesion conspicuity (rated by a radiologist) and the quantitative enhancement of lesions measured as contrast-to-noise ratio. | — |
Countries
Netherlands
Contacts
Public ContactJEM Theunissen
Zuyderland
Outcome results
None listed