Breast Cancer Clinical Trial
Official title:
Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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