Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Lidocaine mucilage-ICG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female at least 18 years old Histologically or cytologically confirmed breast carcinoma Patients planned to receive a breast-conserving surgery Patients received a preoperative breast magnetic resonance imaging Informed consent form understood and signed Patient agrees to all follow-up visits Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery Exclusion Criteria: Psychiatric or other condition that may interfere with the study Known allergy or contraindication to any study drug Patients received neoadjuvant therapies Patients received an excision biopsy of the tumor Breast feeding period Pregnant (female of childbearing potential only)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efficacy of Lidocaine mucilage-ICG<br>Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation | Drug: Lidocaine mucilage-ICG<br>* Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast conserving surgery; fluorescence-guided surgery