NCT06738459 Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer
| NCT ID | NCT06738459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2025-01-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06738459 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06738459 currently recruiting?
Yes, NCT06738459 is actively recruiting participants. Contact the research team at fabio.delben@cro.it for enrollment information.
Where is the NCT06738459 trial being conducted?
This trial is being conducted at Villach, Austria, Austria, Italy, Villach, Italy, Aviano, Italy.
Who is sponsoring the NCT06738459 clinical trial?
NCT06738459 is sponsored by Centro di Riferimento Oncologico - Aviano. The trial plans to enroll 1,500 participants.
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