Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery (LI-CTD)

Shantou Central Hospital

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: Lidocaine mucilage-ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT04438577

ShantouCH

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Efficacy of Lidocaine mucilage-ICG

Experimental group

Description:

Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation

Treatment:

Drug: Lidocaine mucilage-ICG