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RECRUITING
NCT06738459

Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

Sponsor: Centro di Riferimento Oncologico - Aviano

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2025-01-01

Completion Date

2026-07-31

Last Updated

2024-12-17

Healthy Volunteers

Not specified

Conditions

Locations (4)

Landeskrankenhaus Villach

Villach, Austria

KI4LIFE, Fraunhofer Austria Research

Austria, Austria, Italy

Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee

Villach, Austria, Italy

Centro di Riferimento Oncologico

Aviano, Pordenone, Italy