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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00357487
Enrollment
25
Registered
2006-07-27
Start date
2006-06-30
Completion date
2007-12-31
Last updated
2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEperoperative scintillating probe
DEVICEoperative gamma camera

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Louis Pasteur University, Strasbourg
CollaboratorOTHER
Institut Pluridisciplinaire Hubert Curien, Strasbourg
CollaboratorUNKNOWN
University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Depth of the sentinel lymph nodes by a ruler before their excisions.
Radioactivity of the sentinel lymph nodes after their excisions.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026