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

NCT04438577 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-22

No results posted yet for this study

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

Interventions

DRUG

Lidocaine mucilage-ICG

Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Sponsors & Collaborators

  • Shantou Central Hospital

    lead OTHER

Principal Investigators

  • Si-Qi Qiu, Dr. · Shantou Central Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2021-07-31
Completion
2024-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438577 on ClinicalTrials.gov