- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438577
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
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
-
-
Guangdong
-
Shantou, Guangdong, China, 515300
- Recruiting
- Shantou Central Hospital
-
Contact:
- Si-Qi Qiu, Dr.
- Phone Number: 008613790868950
- Email: s_patrick@163.com
-
-
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
|
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
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
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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