NL-OMON33334
Completed
Phase 3
Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - Sentinel node detection with ICG enhanced NIRF optical imaging.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 150
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women above the age of 21 who have biopsy\-proven breast cancer stage I\-II, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Exclusion Criteria
- •Pregnant women, hyperthyroidism, significant renal (serum creatinin \>\= 400 µmol/L), cardiac or pulmonary disease (ASA III\-IV), history of iodine allergy or analfylactic reaction to insect bites or medication.
Outcomes
Primary Outcomes
Not specified
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Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - ICG enhanced SLNBWomen above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedureMedDRA version: 9.1Level: LLTClassification code 10006194Term: Breast cancer NOS stage IMedDRA version: 9.1Level: LLTClassification code 10006195Term: Breast cancer NOS stage IIEUCTR2009-011079-57-NLniversity Medical Center Groningen
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