Breast Cancer, Reasoning, and Activity Intervention
NCT04816006
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT06738459
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Landeskrankenhaus Villach, Villach, Austria
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 2 years
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
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
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
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
Contact information is provided by the study sponsor or research team.
Centro di Riferimento Oncologico - Aviano
Other
Acronym: PRISM
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