diagnostisch onderzoek met als doel tot een optimale planning voor borstsparende chirurgie te komen voor patiënten met mammacarcinoom Breast cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - breast cancer patients eligible for breast conserving therapy - signed informed consent
Exclusion criteria
Exclusion criteria: - contra-indications for MRI - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of irradical lumpectomies The primary goal of additional preoperative imaging and discussion is to reduce the rate of irradical lumpectomies. The histology reports of the specimen will be the reference standard. Assessment of irradicallity will be judged according to national guidelines. The percentage of lumpectomy specimens with positive margins will be documented and compared to that in the historical control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduction of re-operations The number and percentage of re-operations will be documented and compared to that in the historical control group. - Accuracy of tumor size estimation Histology reports of the specimens of all patients will be compared with the outcomes of clinical examination and breast imaging with and without MRI in order to assess extent of tumor and size in mm*s. Correlation coefficients versus histology (as reference standard) will be calculated for the sizes determined by conventional workup and by MRI. - Sensitivity and specificity of the imaging modalities in diagnosing tumor size and extent Histology (as reference standard) of the specimens of all patients will be compared with the outcomes of breast imaging with and without MRI in order to assess sensitivity and specificity of the imaging modalities, and especially MRI, in diagnosing size and extent of the tumor. - Cost-effectiveness of preoperative MRI Finally, a cost-effectiveness analysis of preoperative MRI will be performed, taking into account the costs of clinical examination, the preoperative imaging procedures, the costs of the initial surgical procedures and re-operations, and the effectiveness of radical versus irradical treatment. | — |
Countries
Netherlands
Outcome results
None listed