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

NCT ID: NCT00357487

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

peroperative scintillating probe

Intervention Type: DEVICE

operative gamma camera

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Louis Pasteur University, Strasbourg

OTHER

Sponsor Role: collaborator

Institut Pluridisciplinaire Hubert Curien, Strasbourg

UNKNOWN

Sponsor Role: collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Principal Investigators

Carole Mathelin, MD

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Gyynécologie-Obstétrique -Hôpital Civil

Strasbourg, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 19031925 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18021418 (View on PubMed)

Other Identifiers

3704

Identifier Type: -

Identifier Source: org_study_id