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Sponsors and Collaborators: |
University Hospital, Strasbourg, France Institut Pluridisciplinaire Hubert Curien. UMR 7178 – CNRS/IN2P3 ULP. F-67037 Strasbourg INCa Institut National du cancer. France |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00757302 |
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
Condition | Intervention | Phase |
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Breast Cancer Ductal Carcinoma In Situ |
Device: SLN procedure (CarolIReS camera) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer |
Estimated Enrollment: | 110 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
For the first 10 patients, only a pre-operative procedure will be performed.
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Device: SLN procedure (CarolIReS camera)
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). 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). |
II: Experimental
The last 100 patients will receive the complete procedure.
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Device: SLN procedure (CarolIReS camera)
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). 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). |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: MATHELIN Carole, MD | 33388116071 | carole.mathelin@chru-strasbourg.fr |
France | |
CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique | Recruiting |
Strasbourg, France, 67091 | |
Contact: MATHELIN Carole, MD 33388116071 carole.mathelin@chru-strasbourg.fr | |
Principal Investigator: MATHELIN Carole, MD | |
Sub-Investigator: GHARBI Mousselim, MD | |
Sub-Investigator: LIEGOIS Philippe, MD | |
Sub-Investigator: GRUCKER Daniel, MD | |
Sub-Investigator: CROCE Sabrina, MD | |
Sub-Investigator: MEHL Jean-Louis, MD | |
Sub-Investigator: SCHAEFFER Roland, MD |
Principal Investigator: | MATHELIN Carole, MD | Unaffiliated |
Responsible Party: | Hôpitaux Universitaires de Strasbourg ( Sylvie RISTERUCCI, Directeur Adjoint Chargé des Personnels Médicaux, Direction ) |
Study ID Numbers: | 4126 |
Study First Received: | September 22, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00757302 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
breast cancer CarolIReS intraoperative gamma camera |
lymphoscintigraphy sentinel lymph node Hundred and ten patients with infiltrative breast cancer or ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology. |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Skin Diseases Breast Neoplasms Carcinoma Carcinoma, Ductal Neoplasms Neoplasms by Site |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |