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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.
Multi-wavelength fluorescence has been surveyed in various fields of surgery. However, it was still under investigation, and has not been matured for clinical use. This study will evaluate near infrared zone II spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multispectral near infrared imaging | Other | The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure. Imaging quality will be compared between different spectrums. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infrared fluorescence navigated sentinel lymph node mapping | Procedure | Participants undergo sentinel lymph node biopsy for breast cancer, and use blue dye/Tc99m radioisotope as primary tracer. Indocyanine green near infrared fluorescence as secondary tracer for mapping. |
| 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 |
| 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 |
| Penetration depth | Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast |
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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 |
|---|---|---|---|
| 31873212 | Background | Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23. | |
| 33125289 |
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The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure.
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The patient will know they are going to accept near infrared zone II imaging during the sentinel lymph node biopsy procedure. They will not see the images and will not know the quality results.
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| through study completion, an average of 1 year |
| van Beurden F, van Willigen DM, Vojnovic B, van Oosterom MN, Brouwer OR, der Poel HGV, Kobayashi H, van Leeuwen FWB, Buckle T. Multi-Wavelength Fluorescence in Image-Guided Surgery, Clinical Feasibility and Future Perspectives. Mol Imaging. 2020 Jan-Dec;19:1536012120962333. doi: 10.1177/1536012120962333. |
| 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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