Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- The 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 [Time frame: up to 2 years]
Secondary outcome measures (3)
- Evaluate the changes in lymph node involvement over time [Time frame: up to 2 years]
- Evaluate the association between changes in lymph node involvement and overall survival [Time frame: up to 2 years]
- Evaluate the association between changes in lymph node involvement and progression free survival (PFS) [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- KI4LIFE, Fraunhofer Austria Research — Austria
- Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee — Villach
- Centro di Riferimento Oncologico — Aviano
Austria · 1 center
- Landeskrankenhaus Villach — Villach
Identifiers
NCT: NCT06738459 · CRO-2024-049