Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer (PRISM)

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Fabio Del Ben, PhD; Phone Number: 0434659101; Email: fabio.delben@cro.it

Study Locations

• Austria
  • Villach, Austria, 9500
    • Recruiting
    • Landeskrankenhaus Villach
    • Contact: Thomas Kau; Email: Thomas.Kau@kabeg.at
• Italy
  • Austria, Italy, 9020
    • Recruiting
    • KI4LIFE, Fraunhofer Austria Research
    • Contact: Giacomo Dal Col; Email: giacomo.dacol@fraunhofer.at
  • Austria
    • Villach, Austria, Italy, 9500
      • Recruiting
      • Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee
      • Contact: Bernhard Petrisch; Email: Bernhard.Petritsch@kabeg.at
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro Di Riferimento Oncologico
      • Contact: Fabio Del Ben, PhD; Phone Number: 0434 659101; Email: fabio.delben@cro.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the changes in lymph node involvement over time	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.	up to 2 years
Evaluate the association between changes in lymph node involvement and overall survival	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	up to 2 years
Evaluate the association between changes in lymph node involvement and progression free survival (PFS)	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	up to 2 years

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CRO-2024-049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No