Improving detection of lymph node involvement in breast cancer using advanced imaging techniques
Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer
Centro di Riferimento Oncologico - Aviano · NCT06738459
This study is trying to see if using advanced imaging techniques can help doctors better detect lymph node involvement in breast cancer patients to improve their treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano (other) |
| Locations | 4 sites (Villach and 3 other locations) |
| Trial ID | NCT06738459 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the accuracy of detecting lymph node metastases in breast cancer patients by employing an integrative multidata approach (IMA) that combines clinical and laboratory data with multiparametric MRI. The study focuses on patients diagnosed with breast cancer who have undergone MRI and biopsy or surgery of axillary lymph nodes. By analyzing longitudinal imaging data, the study seeks to address the limitations of current methods, such as sentinel lymph node biopsy, which often yield negative results. The primary goal is to improve staging and treatment planning for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with stage I-III breast cancer who have undergone MRI and biopsy or surgery of axillary lymph nodes.
Not a fit: Patients with insufficient quality MRI images or a previous history of breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of lymph node involvement, improving treatment outcomes for breast cancer patients.
How similar studies have performed: While few studies have explored the use of artificial intelligence in detecting lymph node metastases on MRI, this integrative approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Villach and 3 other locations
- Landeskrankenhaus Villach — Villach, Austria (RECRUITING)
- KI4LIFE, Fraunhofer Austria Research — Austria, Austria, Italy (RECRUITING)
- Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee — Villach, Austria, Italy (RECRUITING)
- Centro di Riferimento Oncologico — Aviano, Pordenone, Italy (RECRUITING)
Study contacts
- Study coordinator: Fabio Del Ben, PhD
- Email: fabio.delben@cro.it
- Phone: 0434659101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer