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

Study Overview
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Brief Summary
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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.

Official Title
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Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: peroperative scintillating probe
* Device: operative gamma camera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infiltrative breast cancer no suspect axillary lymph node no previous radiotherapy no previous chemotherapy no previous breast surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: peroperative scintillating probe|nan|
|Device: operative gamma camera|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of the sentinel lymph nodes by a ruler before their excisions. |  |  | 
| Radioactivity of the sentinel lymph nodes after their excisions. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node, Breast cancer, Lymphoscintigraphy, Probe, Operative gamma camera, Breast cancer and sentinel lymph node biopsy, Use of lymphoscintigraphy, Use of intraoperative gamma camera, Use of intraoperative probe