NCT00357487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

First QC Date

July 26, 2006

Last Update Submit

August 29, 2011

Conditions

Breast Cancer

Keywords

Sentinel lymph nodeBreast cancerLymphoscintigraphyProbeOperative gamma cameraBreast cancer and sentinel lymph node biopsyUse of lymphoscintigraphyUse of intraoperative gamma cameraUse of intraoperative probe

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (2)

  • Depth of the sentinel lymph nodes by a ruler before their excisions.

  • Radioactivity of the sentinel lymph nodes after their excisions.

Interventions

peroperative scintillating probeDEVICE
operative gamma cameraDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gyynécologie-Obstétrique -Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (2)

  • 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.

    PMID: 19031925DERIVED

  • 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.

    PMID: 18021418DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carole Mathelin, MD

    Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2007

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

FR(1)