Clinical trial NCT00357487: Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer
Official title: Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Louis Pasteur University, Strasbourg
name: Institut Pluridisciplinaire Hubert Curien, Strasbourg
First posted: 2006-07-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* infiltrative breast cancer
* no suspect axillary lymph node
* no previous radiotherapy
* no previous chemotherapy
* no previous breast surgery

Primary outcomes:
measure: The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department
measure: The day of the surgery: Preoperative axillary area mapping with the operative gamma camera. Search of sentinel lymph nodes with the probe
measure: Post operative axillary area imaging with the operative gamma camera.
Secondary outcomes:
measure: Depth of the sentinel lymph nodes by a ruler before their excisions.
measure: Radioactivity of the sentinel lymph nodes after their excisions.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gyynécologie-Obstétrique -Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Carole Mathelin, MD
role: STUDY_DIRECTOR
References:
citation: Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liegeois 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.
citation: Mathelin C, Salvador S, Croce S, Andriamisandratsoa N, Huss D, Guyonnet JL. Optimization of sentinel lymph node biopsy in breast cancer using an operative gamma camera. World J Surg Oncol. 2007 Nov 17;5:132. doi: 10.1186/1477-7819-5-132.