Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

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

Eligibility criteria

Qualifiers

Patients diagnosed with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment

Patients of all genders, ages, and stage I-III of breast cancer

Patients who underwent neoadjuvant therapy and have longitudinal imaging data available for analysis (for secondary outcome analysis)

Disqualifiers

Patients whose MRI images were of insufficient quality for analysis

Patients who had a previous history of breast cancer

Patients with a history of axillary surgery or lymph node dissection prior to the current diagnosis of breast cancer

Patients who received neoadjuvant therapy at another institution

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed