Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer
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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 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.
| 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:
- infiltrative breast cancer
- no suspect axillary lymph node
- no previous radiotherapy
- no previous chemotherapy
- no previous breast surgery
Contacts and Locations| France | |
| Service de Gyynécologie-Obstétrique -Hôpital Civil | |
| Strasbourg, France, 67091 | |
| Study Director: | Carole Mathelin, MD | Hôpitaux Universitaires de Strasbourg |
More Information
No publications provided by University Hospital, Strasbourg, France
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00357487 History of Changes |
| Other Study ID Numbers: | 3704 |
| Study First Received: | July 26, 2006 |
| Last Updated: | August 29, 2011 |
| Health Authority: | France: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on May 22, 2013