NCT04438577

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shantou Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Lidocaine mucilage-ICG	Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Timeline

• Start date: 2020-08-20
• Primary completion: 2021-07-01
• Completion: 2024-01-01
• First posted: 2020-06-19
• Last updated: 2020-10-22

Locations

1 site across 1 country: China