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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Drug: Lidocaine mucilage-ICG

• Registration Number: NCT04438577
• Lead Sponsor: Shantou Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2020-08-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-07
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Efficacy of Lidocaine mucilage-ICG	Lidocaine mucilage-ICG	Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation

Primary Outcome Measures

Name	Time	Method
Positive margin rate	7 days	The percentage of patients with a positive margin out of the participants
Margin width	7 days	The distance between tumor and margin on the gross specimen

Trial Locations

Locations (1)

Shantou Central Hospital; 🇨🇳 Shantou, Guangdong, China