Status:
COMPLETED
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presenc...
Eligibility Criteria
Inclusion
- Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
- Unifocal or multifocal but in same quarter
- Size \< 5cm clinically palpable or not
- Clinically or ultrasound axillary N0
- Isotopic sentinel node detection
- Adult patient
- Signed informed consent by patient or legally responsable authority
- Patient registered to a social security system
- No surgical contra-indication
Exclusion
- Mammary carcinoma recurrence
- Previous same side mammary reduction
- Previous lumpectomy
- Contra-indication to surgery
- Pregnant or breast feeding patient
- Denial of participation
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02279108
Start Date
November 1 2014
End Date
July 1 2016
Last Update
April 9 2018
Active Locations (1)
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1
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France, 42055