Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer
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.
Device: peroperative scintillating probe
Device: operative gamma camera
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera|
- 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.
- Depth of the sentinel lymph nodes by a ruler before their excisions.
- Radioactivity of the sentinel lymph nodes after their excisions.
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357487
|Service de Gyynécologie-Obstétrique -Hôpital Civil|
|Strasbourg, France, 67091|
|Study Director:||Carole Mathelin, MD||Hôpitaux Universitaires de Strasbourg|