breast cancer breast neoplasma
Conditions
Interventions
For the intervention group, rapid access to CESM is guaranteed. Prior to the
exam, a questionnaire will be used to screen for risk factors for using
iodine-based contrast agents (this is common prac
(2) a negative CESM exam with no suspect lesion on both low-energy and
recombined image
(3) CESM exam, including targeted ultrasound, and core biopsy
or fine needle cytology aspiration for pathological diagnosis
(4) like group
3. Since many false-positive recalls are caused either by cysts or by
superimpos
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Included are women able to provide informed consent and recalled from breast cancer screening for a suspicious breast lesion during the 18-month study inclusion period.
Exclusion criteria
Exclusion criteria: Exclusion criteria are contra-indications for the use of iodine-based contrast agents (allergies), severe renal insufficiency or risk for contrast-induced nephropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters are the diagnostic performance of CESM as compared to conventional mammography, defined as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), area under the ROC curve (AUC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes are days to final diagnosis for both study arms, patient experienced anxiety (as measured by State-Trait Anxiety Inventory (STAI) and EQ5D questionnaires) for both approaches, and a cost-effectiveness and budget impact analysis. | — |
Countries
Netherlands
Outcome results
None listed