Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357487
• Other study ID #: 3704
• Status: Completed
• Phase: N/A
• First received: July 26, 2006
• Last updated: August 29, 2011
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: August 2011
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infiltrative breast cancer

• no suspect axillary lymph node

• no previous radiotherapy

• no previous chemotherapy

• no previous breast surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• peroperative scintillating probe

• operative gamma camera

Locations

Country	Name	City	State
France	Service de Gyynécologie-Obstétrique -Hôpital Civil	Strasbourg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	France: Centre National de la Recherche Scientifique, Institut Pluridisciplinaire Hubert Curien, Strasbourg, Louis Pasteur University, Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department
Primary	The day of the surgery: Preoperative axillary area mapping with the operative gamma camera. Search of sentinel lymph nodes with the probe
Primary	Post operative axillary area imaging with the operative gamma camera.
Secondary	Depth of the sentinel lymph nodes by a ruler before their excisions.
Secondary	Radioactivity of the sentinel lymph nodes after their excisions.