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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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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.
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. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voluven diluted indocyanine green | Experimental | This arm participants uses Voluven diluted ICG for sentinel lymph node mapping. |
|
| Distilled-water diluted indocyanine green | Active Comparator | This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infrared fluorescence navigated sentinel lymph node mapping | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-background ratio (SBR) | Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background. | through study completion, an average of 1 year |
| Penetration depth | Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph nodes pathology | The positivity and number of retrieved sentinel lymph nodes at definitive pathology report. | through study completion, an average of 1 year |
| Time to total visualization of breast subcutaneous lymphatics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yung-Chun Hsieh, MD | Contact | +886-972322925 | abitzsong@gmail.com | |
| Yang-Hsiang Chan, PhD | Contact | +886-966626689 | yhchan@nycu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yung-Chun Hsieh, MD | National Taiwan University Hospital Hsin-Chu Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital | Recruiting | Zhubei | HsinChu County | 302 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21360250 | Background | 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. |
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The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.
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The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
|
The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics
| through study completion, an average of 1 year |
| 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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