Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
- Registration Number
- NCT02279108
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
- 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
- Mammary carcinoma recurrence
- Previous same side mammary reduction
- Previous lumpectomy
- Contra-indication to surgery
- Pregnant or breast feeding patient
- Denial of participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description isotope detection alone isotope intradermal injection of 20 MBq of technetium 99 before breast surgery double detection Indocyanine + isotope isotope intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery double detection Indocyanine + isotope indocyanine green intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
- Primary Outcome Measures
Name Time Method Number of Patients With Less Than Two Lymph Nodes Detected peroperative Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
- Secondary Outcome Measures
Name Time Method Number of Lymph Nodes ICG Positive and Tc Positive Peroperative Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Comparison Between Groups of the Time of the Surgery Peroperative time from incision to wound closure
Comparison Between Groups of Time Surgery Node Peroperative time from incision time to the last node surgery
Number of Patients With ICG Allergy Month 2 allergy is : redness, edema, itching, larynges edema and/or allergic shock
Number of Lymph Nodes ICG Positive and Tc Negative Peroperative Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Comparison Between Groups of Anesthesia Time Peroperative time from the injection of anesthesic to the waking
Number of Lymph Nodes ICG Negative and Tc Positive Peroperative Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Time From Injection of One Dose ICG Injection to Incision Time Peroperative time from injection of one dose ICG injection to incision time
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Saint-Etienne
🇫🇷Saint-Etienne, France