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OpenTrials
Completed

NCT Number: NCT00357487

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gyynécologie-Obstétrique -Hôpital Civil

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

peroperative scintillating probe

Device

operative gamma camera

Device

Primary outcomes

  1. The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department

  2. The day of the surgery: Preoperative axillary area mapping with the operative gamma camera. Search of sentinel lymph nodes with the probe

  3. Post operative axillary area imaging with the operative gamma camera.

Secondary outcomes

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

  2. Radioactivity of the sentinel lymph nodes after their excisions.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Institut Pluridisciplinaire Hubert Curien, Strasbourg
  • Louis Pasteur University, Strasbourg

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jul 27, 2006
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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