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Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

NCT ID: NCT06738459

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Landeskrankenhaus Villach

Villach, , Austria

Site Status RECRUITING

KI4LIFE, Fraunhofer Austria Research

Austria, Austria, Italy

Site Status RECRUITING

Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee

Villach, Austria, Italy

Site Status RECRUITING

Centro di Riferimento Oncologico

Aviano, Pordenone, Italy

Site Status RECRUITING

Countries

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Austria Italy

Central Contacts

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Fabio Del Ben, PhD

Role: CONTACT

Phone: 0434659101

Email: [email protected]

Facility Contacts

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Thomas Kau

Role: primary

Giacomo Dal Col

Role: primary

Bernhard Petrisch

Role: primary

Fabio Del Ben, PhD

Role: primary

Other Identifiers

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CRO-2024-049

Identifier Type: -

Identifier Source: org_study_id