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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04438577

Acronym

LI-CTD

Enrollment

Registered

2020-06-19

Start date

2020-08-20

Completion date

2024-01-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast conserving surgery; fluorescence-guided surgery

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.

Interventions

DRUGLidocaine mucilage-ICG

Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactMian-Han Zhuang

jgbst@163.com008613750445342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026