Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00757302
Brief Summary:
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
Detailed Description:
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.
Study:
NCT00757302
Study Brief:
Protocol Section:
NCT00757302