Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Lidocaine mucilage-ICG

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2020
See protocol details

Summary

Principal SponsorShantou Central Hospital
Study ContactMian-Han Zhuang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2020

Actual date on which the first participant was enrolled.

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 TitleEvaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
NCT04438577
Principal SponsorShantou Central Hospital
Study ContactMian-Han Zhuang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
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
Show More Criteria
6 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shantou Central Hospital

Shantou, ChinaOpen Shantou Central Hospital in Google Maps
SuspendedOne Study Center