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| Tracking Information | |||||
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| First Received Date ICMJE | July 26, 2006 | ||||
| Last Updated Date | March 8, 2007 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00357487 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer | ||||
| Official Title ICMJE | Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-Operative Probe and a Mini Gamma Camera | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00357487 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 3704 | ||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Strasbourg, France | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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