Breast cancer Breast cancer
Conditions
Interventions
CT scan with contrast 
MRI scan with contrast 
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must have given written informed consent Women aged 18 years and older who received a BI-RADS score of 4 or 5 due to suspicious calcifications detected on mammography during breast cancer screening
Exclusion criteria
Exclusion criteria: History of allergic reactions to iodinated or gadolinium contrast agents Pregnancy or breast feedingContraindications for MRI such as metal implants, pacemakers, implantable cardioverter defibrillator (ICD), claustrophobiaRecent treatment (<8 weeks ago) of thyroid disease with radioactive iodineUse of metforminRenal Impairment (eGFR < 30 mL/min)Chronic or acutely worsening renal diseasePatients who are declared incompetent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCCT scan with contrast vs mammographyAssessment of calcifications (feasibility, distribution, and morphology) on PCCT using reader assessment protocol. The results will be compared with mammography.DCE-MRI vs PCCT with contrast Assessment of contrast enhanced areas in breast on PCCT and DCE-MRI Sensitivity, specificity, positive and negative predictive value of PCCT and DCE-MRI will be calculated. Histopathology will serve as the reference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate patient preferences, comfort levels, and confidence in diagnostic outcomes for PCCT, DCE-MRI, and stereotactic VABB using a validated, patient-informed multiple-choice questionnaire. | — |
Countries
Netherlands
Contacts
Public ContactS.D. Joomun
Universitair Medisch Centrum Groningen
Outcome results
None listed