Intraoperative Gamma Camera for Breast Cancer Surgery
Intraoperative Gamma Camera for Breast Cancer Surgery
Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field
 of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of
 sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be
 performed on 110 patients and the CarolIReS camera will be used preoperatively to localize
 SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named
 CarolIReS and their activity will be measured with a gamma ray counter. At the end of
 surgery, the CarolIReS camera will be used again to check the quality of surgery which will
 be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective
 of this study is to evaluate the performances of the CarolIReS camera in assessing the
 axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the
 possible correlation between the activity, the size, and the metastatic involvement of the
 SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve
 the efficiency of the SLN procedure
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.