Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00357487
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Study Completion: 2007-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• infiltrative breast cancer
• no suspect axillary lymph node
• no previous radiotherapy
• no previous chemotherapy
• no previous breast surgery

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department
The day of the surgery: Preoperative axillary area mapping with the operative gamma camera. Search of sentinel lymph nodes with the probe
Post operative axillary area imaging with the operative gamma camera.

Secondary Outcome Measures

Name	Time	Method
Radioactivity of the sentinel lymph nodes after their excisions.
Depth of the sentinel lymph nodes by a ruler before their excisions.

Trial Locations

Locations (1)

Service de Gyynécologie-Obstétrique -Hôpital Civil; 🇫🇷 Strasbourg, France