RecruitingNCT06329089

Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer

RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches


Sponsor

Hospital Clinic of Barcelona

Enrollment

97 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are: * What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries? * How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit? Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a sentinel lymph node biopsy can be successfully repeated in women with recurring breast cancer in the same breast who have already had previous lymph node surgery. Sentinel lymph node biopsy is a less invasive procedure than full lymph node removal, and researchers want to know if it can still accurately detect cancer spread in recurrent disease. **You may be eligible if...** - You are over 18 years old - You have a local recurrence (cancer came back in the same breast/chest area) confirmed by biopsy - Your cancer is classified as clinical stage cT1–T3 with no lymph node involvement on imaging - You have had previous axillary (armpit) lymph node surgery (either sentinel node biopsy or full lymph node removal) **You may NOT be eligible if...** - You have confirmed cancer in your lymph nodes (axillary metastasis) - You have inflammatory breast cancer - Imaging shows suspected distant spread - You are allergic to the radiotracer used in the sentinel node procedure, or have mobility limitations that prevent the technique Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREReoperative Sentinel Lymph Node Biopsy

Reoperative sentinel lymph node biopsy refers to a surgical procedure performed when there is a need to re-examine the sentinel lymph nodes (SLNs) in patients who have previously undergone breast cancer surgery. The sentinel lymph nodes are the first lymph nodes to which cancer cells are likely to spread from the primary tumor. During the procedure, the surgeon locates and removes the previously identified sentinel lymph nodes using techniques such as lymphatic mapping and injection of a radiotracer or dye. The removed lymph nodes are then examined by a pathologist to determine if there is any evidence of cancer spread.


Locations(1)

Hospital Clínic de Barcelona

Barcelona, Spain

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NCT06329089


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