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Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy of Lidocaine mucilage-ICG | Experimental | Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine mucilage-ICG | Drug | Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Margin width | The distance between tumor and margin on the gross specimen | 7 days |
| Positive margin rate | The percentage of patients with a positive margin out of the participants | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mian-Han Zhuang | Contact | 008613750445342 | jgbst@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Si-Qi Qiu, Dr. | Shantou Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shantou Central Hospital | Recruiting | Shantou | Guangdong | 515300 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |