A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
NCT ID: NCT05365204
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2022-04-08
2023-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Voluven diluted indocyanine green
This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.
Near infrared fluorescence navigated sentinel lymph node mapping
Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.
Distilled-water diluted indocyanine green
This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.
Near infrared fluorescence navigated sentinel lymph node mapping
Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.
Interventions
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Near infrared fluorescence navigated sentinel lymph node mapping
Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Yang Ming Chiao Tung University
OTHER
National Taiwan University Hospital Hsin-Chu Branch
OTHER
Responsible Party
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Principal Investigators
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Yung-Chun Hsieh, MD
Role: STUDY_CHAIR
National Taiwan University Hospital Hsin-Chu Branch
Locations
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National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
Zhubei, HsinChu County, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
Other Identifiers
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111-009-F
Identifier Type: -
Identifier Source: org_study_id
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