Intraoperative Gamma Camera for Breast Cancer Surgery

Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section.

Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section. After SLN removal and during the pathological analysis, the axillary area will once again be checked using the CarolIReS camera (followed by a further surgical excision in the case of remaining SLNs).

When the pathological analysis will diagnose a metastatic SLN, complete axillary lymph node dissection (ALND) will immediately be performed. In the case of negative SLN, serial sections and detection of cytokeratine (AE1/AE3; Dako, Zymed, CA, USA) will be performed during standard pathological analysis. Macrometastases will be defined as clusters of cancer cells ≥2 mm, micrometastases as clusters of cancer cells ≥0.2 mm and <2 mm, and isolated cancer cells as clusters of cancer cells <0.2 mm. ALND will be performed in cases of macro- or micrometastases.

Inclusion criteria

• Patient major at the time of breast surgery.
• Patient affiliated with a social security.
• Consent dated and signed by the investigator and the subject.
• Subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
• Patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
• Patient having a ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.

Exclusion criteria

• Refusal of the patient to be included in the study.
• Pregnant patient or during breastfeeding.
• None of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
• Diagnosed safeguarding justice and trust.
• Patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
• Prevalent axillary lymph node.