Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: indocyanine green
* Drug: isotope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…) Unifocal or multifocal but in same quarter Size < 5cm clinically palpable or not Clinically or ultrasound axillary N0 Isotopic sentinel node detection Adult patient Signed informed consent by patient or legally responsable authority Patient registered to a social security system No surgical contra-indication Exclusion Criteria: Mammary carcinoma recurrence Previous same side mammary reduction Previous lumpectomy Contra-indication to surgery Pregnant or breast feeding patient Denial of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: double detection Indocyanine + isotope<br>intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery | Drug: indocyanine green<br>* One injection, 2.5 milligrams per patient, intradermal use<br>Drug: isotope<br>* One injection, 20 MBq techntium99, intradermal use<br>* Other names: technetium;|
| Active Comparator: isotope detection alone<br>intradermal injection of 20 MBq of technetium 99 before breast surgery | Drug: isotope<br>* One injection, 20 MBq techntium99, intradermal use<br>* Other names: technetium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | peroperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lymph Nodes ICG Positive and Tc Positive | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive | Peroperative | 
| Number of Lymph Nodes ICG Positive and Tc Negative | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative | Peroperative | 
| Number of Lymph Nodes ICG Negative and Tc Positive | Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive | Peroperative | 
| Comparison Between Groups of the Time of the Surgery | time from incision to wound closure | Peroperative | 
| Comparison Between Groups of Anesthesia Time | time from the injection of anesthesic to the waking | Peroperative | 
| Time From Injection of One Dose ICG Injection to Incision Time | time from injection of one dose ICG injection to incision time | Peroperative | 
| Comparison Between Groups of Time Surgery Node | time from incision time to the last node surgery | Peroperative | 
| Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | peroperative | 
| Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | 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 | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer