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Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer
This study has been completed.
Study NCT00357487   Information provided by University Hospital, Strasbourg, France
First Received: July 26, 2006   Last Updated: March 8, 2007   History of Changes

July 26, 2006
March 8, 2007
June 2006
 
  • 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.
Same as current
Complete list of historical versions of study NCT00357487 on ClinicalTrials.gov Archive Site
  • Depth of the sentinel lymph nodes by a ruler before their excisions.
  • Radioactivity of the sentinel lymph nodes after their excisions.
Same as current
 
Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer
Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-Operative Probe and a Mini Gamma Camera

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.

 
 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Breast Cancer
  • Device: peroperative scintillating probe
  • Device: operative gamma camera
 
Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liégeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
25
December 2007
 

Inclusion Criteria:

  • infiltrative breast cancer
  • no suspect axillary lymph node
  • no previous radiotherapy
  • no previous chemotherapy
  • no previous breast surgery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00357487
 
3704
University Hospital, Strasbourg, France
  • France: Centre National de la Recherche Scientifique
  • Louis Pasteur University, Strasbourg
  • Institut Pluridisciplinaire Hubert Curien, Strasbourg
Study Director: Carole Mathelin, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP