Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

NCT06738459 | Recruiting

• 1 other identifier: CRO-2024-049
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 4

Brief 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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Sensitivity, specificity, positive predictive value, and negative predictive value of the integrative model will be calculated to evaluate the diagnostic performance of the model.

  up to 2 years

Secondary Outcomes (3)

• Evaluate the changes in lymph node involvement over time

  up to 2 years

• Evaluate the association between changes in lymph node involvement and overall survival

  up to 2 years

• Evaluate the association between changes in lymph node involvement and progression free survival (PFS)

  up to 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment at the involved centers. Patients of all genders, ages, and stages I-III of breast cancer will be included in the study. Patients with incomplete data or whose MRI images were of insufficient quality for analysis will be excluded.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (4)

Landeskrankenhaus Villach

Villach, 9500, Austria

RECRUITING

KI4LIFE, Fraunhofer Austria Research

Austria, Austria, 9020, Italy

RECRUITING

Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee

Villach, Austria, 9500, Italy

RECRUITING

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Fabio Del Ben, PhD

CONTACT

0434659101; fabio.delben@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

AU (1); IT (3)