RecruitingNCT06738459

Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer


Sponsor

Centro di Riferimento Oncologico - Aviano

Enrollment

1,500 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses MRI scans and tissue samples collected during routine breast cancer care to build better models for predicting whether lymph nodes (the small glands that cancer can spread to) are affected. The goal is to improve how doctors assess the spread of breast cancer without needing additional invasive procedures. **You may be eligible if...** - You have been diagnosed with breast cancer (any gender, stage I–III) - You already had an MRI and a biopsy or surgery of the underarm lymph nodes as part of your standard care - You received treatment before surgery (neoadjuvant therapy) and have imaging data over time available **You may NOT be eligible if...** - Your MRI images were too poor quality for analysis - You had a prior history of breast cancer before this diagnosis - You do not have the required imaging or biopsy data available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06738459


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