The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice. So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough. Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable. The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
99
One injection, 2.5 milligrams per patient, intradermal use
One injection, 20 MBq techntium99, intradermal use
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France
Number of Patients With Less Than Two Lymph Nodes Detected
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
Time frame: peroperative
Number of Lymph Nodes ICG Positive and Tc Positive
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Time frame: Peroperative
Number of Lymph Nodes ICG Positive and Tc Negative
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Time frame: Peroperative
Number of Lymph Nodes ICG Negative and Tc Positive
Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Time frame: Peroperative
Comparison Between Groups of the Time of the Surgery
time from incision to wound closure
Time frame: Peroperative
Comparison Between Groups of Anesthesia Time
time from the injection of anesthesic to the waking
Time frame: Peroperative
Time From Injection of One Dose ICG Injection to Incision Time
time from injection of one dose ICG injection to incision time
Time frame: Peroperative
Comparison Between Groups of Time Surgery Node
time from incision time to the last node surgery
Time frame: Peroperative
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: peroperative
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: 1 hour after the end of the surgery
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: Month 2
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