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| Sponsor: | University Hospital, Strasbourg, France |
|---|---|
| Collaborators: |
France: Centre National de la Recherche Scientifique Louis Pasteur University, Strasbourg Institut Pluridisciplinaire Hubert Curien, Strasbourg |
| Information provided by: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00357487 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-Operative Probe and a Mini Gamma Camera |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| France | |
| Service de Gyynécologie-Obstétrique -Hôpital Civil | |
| Strasbourg, France, 67091 | |
| Study Director: | Carole Mathelin, MD | Hôpitaux Universitaires de Strasbourg |
More Information
| Study ID Numbers: | 3704 |
| Study First Received: | July 26, 2006 |
| Last Updated: | March 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00357487 History of Changes |
| Health Authority: | France: Ministry of Health |
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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 |
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Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |