Accurate assessment of axillary lymph nodes in patients with breast cancer is essential for prognosis and treatment planning. Staging and surgical management have evolved from axillary lymph node dissection to sentinel lymph node biopsy to minimize morbidity. However, sentinel lymph node biopsy has non-negligible morbidity, and more than 70% of biopsies are negative, calling into question its routine use. Magnetic resonance imaging (MRI) can be used to detect and stage lymph node metastases in situ, but its sensitivity and specificity are moderate to poor. Few studies have employed artificial intelligence to detect lymph node metastases on MRI images, and none have used an integrative multidata approach (IMA), defined as modeling the combination of clinical and laboratory data with multiparametric MRI. The primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement
Study Type
OBSERVATIONAL
Enrollment
1,500
Landeskrankenhaus Villach
Villach, Austria
RECRUITINGKI4LIFE, Fraunhofer Austria Research
Austria, Austria, Italy
RECRUITINGKlinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee
Villach, Austria, Italy
RECRUITINGCentro di Riferimento Oncologico
Aviano, Pordenone, Italy
RECRUITINGThe accuracy of detecting lymph node involvement using multiparametric MRI, clinical characteristics, and laboratory data, and to compare it to the accuracy of detecting lymph node involvement using MRI alone
Sensitivity, specificity, positive predictive value, and negative predictive value of the integrative model will be calculated to evaluate the diagnostic performance of the model.
Time frame: up to 2 years
Evaluate the changes in lymph node involvement over time
The effects of neoadjuvant therapy will be estimated as the difference in the rate of lymph node involvement before and after neoadjuvant therapy, with corresponding 95% confidence intervals.
Time frame: up to 2 years
Evaluate the association between changes in lymph node involvement and overall survival
Association between changes in lymph node involvement and overall survival (OS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) OS will be calculated from neoajuvant treatment start to death or end of follow up whichever came first
Time frame: up to 2 years
Evaluate the association between changes in lymph node involvement and progression free survival (PFS)
Association between changes in lymph node involvement and overall survival (PFS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) PFS will be calculated from neoajuvant treatment start to progression, death or end of follow up whichever came first
Time frame: up to 2 years
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