Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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)

Locations
Other Locations
Austria
Landeskrankenhaus Villach
RECRUITING
Villach
Italy
KI4LIFE, Fraunhofer Austria Research
RECRUITING
Austria
Centro di Riferimento Oncologico
RECRUITING
Aviano
Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee
RECRUITING
Villach
Contact Information
Primary
Fabio Del Ben, PhD
fabio.delben@cro.it
0434659101
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 1500
Related Therapeutic Areas
Sponsors
Leads: Centro di Riferimento Oncologico - Aviano

This content was sourced from clinicaltrials.gov