Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery (LI-CTD)

October 20, 2020 updated by: Si-Qi Qiu, Shantou Central Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mian-Han Zhuang
  • Phone Number: 008613750445342
  • Email: jgbst@163.com

Study Locations

  • China
    • Guangdong
      • Shantou, Guangdong, China, 515300
        • Recruiting
        • Shantou Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efficacy of Lidocaine mucilage-ICG
Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation
Drug: Lidocaine mucilage-ICG
Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shantou Central Hospital

Investigators

  • Principal Investigator: Si-Qi Qiu, Dr., Shantou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShantouCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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