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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357487
First Posted: July 27, 2006
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre National de la Recherche Scientifique, France
Louis Pasteur University, Strasbourg
Institut Pluridisciplinaire Hubert Curien, Strasbourg
Information provided by:
University Hospital, Strasbourg, France
  Purpose
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.

Condition Intervention
Breast Cancer Device: peroperative scintillating probe Device: operative gamma camera

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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:
  • Depth of the sentinel lymph nodes by a ruler before their excisions.
  • Radioactivity of the sentinel lymph nodes after their excisions.

Estimated Enrollment: 25
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infiltrative breast cancer
  • no suspect axillary lymph node
  • no previous radiotherapy
  • no previous chemotherapy
  • no previous breast surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357487


Locations
France
Service de Gyynécologie-Obstétrique -Hôpital Civil
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Centre National de la Recherche Scientifique, France
Louis Pasteur University, Strasbourg
Institut Pluridisciplinaire Hubert Curien, Strasbourg
Investigators
Study Director: Carole Mathelin, MD Hôpitaux Universitaires de Strasbourg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00357487     History of Changes
Other Study ID Numbers: 3704
First Submitted: July 26, 2006
First Posted: July 27, 2006
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Strasbourg, France:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases