Status:
COMPLETED
Intraoperative Gamma Camera for Breast Cancer Surgery
Lead Sponsor:
University Hospital, Strasbourg, France
Collaborating Sponsors:
Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3
ULP. F-67037 Strasbourg
Conditions:
Breast Cancer
Ductal Carcinoma in Situ
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
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, Fra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00757302
Start Date
September 1 2008
End Date
September 1 2014
Last Update
December 22 2025
Active Locations (1)
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1
CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique
Strasbourg, France, 67091