Breast cancer breast tumor
Conditions
Interventions
None listed
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Included women are older than 18 years of age, with a recent finding on CEM requiring CESB (a so-called 'recombined image only lesion' or ROL). Only women able to provide written informed consent will be considered for this study.
Exclusion criteria
Exclusion criteria: Excluded are all men (male sex), and women (female sex) who are contra-indicated for CESB (for example, with impaired renal function or known hypersensitivity reactions to iodinated contrast). Also excluded are pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study aim will be to calculate the cumulative diagnostic yield per specimen, enabling us to define a minimum number of biopsies required (or tissue volume needed) to establish a reliable diagnosis using CESB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes will be general parameters of the biopsy procedure itself, such as patient characteristics, histopathological results, pain experienced during the procedure, and complication rates (hematoma, infection). | — |
Countries
Netherlands
Outcome results
None listed