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| ID | Type | Description | Link |
|---|---|---|---|
| 114-BIH052 | Other Grant/Funding Number | National Taiwan University Hospital Hsinchu Branch |
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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
| National Taiwan University Hospital Hsin-Chu Branch | OTHER |
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The goal of this clinical trial is to exploring the use of Mannitol 20% as a solvent to prepare ICG solution, combining with Voluven, forming a hybrid small-large molecular weight solvent for protecting ICG in monomer form and stimulating lymphatic uptake simultaneously in early breast cancer patients who is indicated to undergo sentinel lymph node biopsy. The main question it aims to answer is:
Researchers will compare the following arms with different solvent (all arms' final ICG concentration are 0.25mg/mL):
Participants will be invited in a group of 3, and be blindly assigned to each concentration group sequentially. Participants will undergo ICG fluorescence guided sentinel lymph node biopsy with the assigned solution formula. The endpoints included number of lymph nodes obtained, fluorescence signal-to-background ratio of the lymph nodes, lymphatic uptake rate, lymphatic drainage speed, detection method, lymph node pathology, and any intra- or post-operative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pure Voluven | Active Comparator | The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution. |
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| 1:10 | Active Comparator | The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution. |
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| 1:8 | Active Comparator | The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution. |
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| 1:6 | Active Comparator | The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution. |
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| 1:4 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer | Procedure | The procedure includes: (1) preparation of specific formula of ICG:Voluven solution (2) injection of ICG solution at subarelar area or peri-tumoral area (3) observation of fluorescent lymphatic drainage and retrieval of sentinel lymph nodes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sentinel lymph nodes | The number of the retrieved sentinel lymph nodes | From the procedure day to the follow-up clinic visit day (average 10 days) |
| Fluorescence signal-to-background ratio of the lymph nodes | From the procedure day to the follow-up clinic visit day (average 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphatic uptake rate | The time from injection to the development of fluorescent subcutaneous lymphatics | From the procedure day to the follow-up clinic visit day (average 10 days) |
| Lymphatic drainage speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yung Chun Hsieh, M.D., MMSC | National Taiwan University Hospital Hsinchu Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsinchu Branch | Hsinchu County | 302 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37605084 | Background | Hsieh YC, Guo KW, Wang MW, Su SP, Syu YH, Huang CS, Chan YH. A Novel Injection Protocol Using Voluven(R)-Assisted Indocyanine Green with Improved Near-Infrared Fluorescence Guidance in Breast Cancer Sentinel Lymph Node Mapping-A Translational Study. Ann Surg Oncol. 2023 Dec;30(13):8419-8427. doi: 10.1245/s10434-023-14129-4. Epub 2023 Aug 21. |
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The study is a dose-escalation trial of adding Mannitol into Voluven-ICG solution as solvent/adjunct. The patients will be invited in groups of three, and the proportion of Mannitol will be escalated in the sequential groups.
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The participants will not know which concentration group they are assigned to.
The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
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| Mannitol (20%) | Drug | Adding Mannitol into Voluven and used as solvent of ICG |
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The time from the initiation of visible fluorescent subcutaneous lymphatics to that reaches the axilla
| From the procedure day to the follow-up clinic visit day (average 10 days) |
| Detection method | The method of the sentinel lymph node being detected. (Could be radioisotope, blye dye, ICG fluorescence, or combination of multiple methods) | From the procedure day to the follow-up clinic visit day (average 10 days) |
| Lymph node pathology | The positivity of sentinel lymph node metastasis in the pathology report. | From the procedure day to the follow-up clinic visit day (average 10 days) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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