Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy

NCT03556397

Breast Cancer

COMPLETED NA

Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients

NCT00507611

Invasive Breast Cancer

COMPLETED NA

Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

NCT01804309

Breast Cancer

COMPLETED

Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI

NCT04826211

Breast Cancer Female Node-positive Breast Cancer Sentinel Lymph Node

COMPLETED NA

Predictive Model of Axillary Nodal Status After Neoadjuvant Chemotherapy in Breast Cancer Patients

NCT05798806

Breast Cancer

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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