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NCT Number: NCT06738459

Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landeskrankenhaus Villach, Villach, Austria

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: up to 2 years

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

Secondary outcomes

  1. Evaluate the changes in lymph node involvement over time

    Time frame: up to 2 years

    The effects of neoadjuvant therapy will be estimated as the difference in the rate of lymph node involvement before and after neoadjuvant therapy, with corresponding 95% confidence intervals.

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

    Time frame: up to 2 years

    Association between changes in lymph node involvement and overall survival (OS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) OS will be calculated from neoajuvant treatment start to death or end of follow up whichever came first

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

    Time frame: up to 2 years

    Association between changes in lymph node involvement and overall survival (PFS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) PFS will be calculated from neoajuvant treatment start to progression, death or end of follow up whichever came first

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Del Ben, PhD

CONTACT

[email protected]

0434659101

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Acronym: PRISM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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