Status:
UNKNOWN
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
Lead Sponsor:
National Taiwan University Hospital Hsin-Chu Branch
Collaborating Sponsors:
National Yang Ming Chiao Tung University
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.
Detailed Description
Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Simil...
Eligibility Criteria
Inclusion
- Breast cancer, adults
Exclusion
- Patient aged \< 20 years old
- Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
- Patient who is allergic to primary tracers (including Tc99m and blue dye)
- Patient who is allergic to indocyanine green
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 7 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05365204
Start Date
April 8 2022
End Date
April 7 2023
Last Update
May 9 2022
Active Locations (1)
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1
National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
Zhubei, HsinChu County, Taiwan, 302