Breast lesions that require an MR-guided biopsy for diagnosis Breast abnormalities
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must have given written informed consentFemales aged 18 years and overIndication for a MR-guided breast biopsy
Exclusion criteria
Exclusion criteria: CT-related contraindications:History of allergic reactions to iodinated contrast agentsPregnancy or breast feedingRecent treatment (<8 weeks ago) of thyroid disease with radioactive iodineUse of metforminCreatinine clearance < 45 mL/minChronic or acutely worsening renal diseaseOther contraindications:Patients who are declared incompetent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On multi-energy CT, the breast lesions will be compared to surrounding tissues in terms of iodine uptake, normalized iodine uptake and spectral slope between 40 and 70 keV. The qualitative assessment will be done by three breast radiologists who will identify the breast lesions and rate the amount of background enhancement on multi-energy CT and compare it to DCE-MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze radiation exposure of each multi-energy CT scan. Effective dose will be estimated as follows:Effective dose (mSv) = DLP (mGycm) conversion factor for the chest (mSv/mGycm)The CTDIvol will be used to calculate the DLP and the conversion factor for the chest is 0.0145 mSv/mGycmTo assess patient experience using a visual analog scale (VAS) for different modalities, including DCE-MRI, MRI-guided biopsy and multi-energy CT. | — |
Countries
Netherlands
Contacts
Rijnstate