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

NCT04438577 | Unknown DMC

• 1 other identifier: ShantouCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast conserving surgery; fluorescence-guided surgery

Outcome Measures

Primary Outcomes (2)

• Margin width

  The distance between tumor and margin on the gross specimen

  7 days

• Positive margin rate

  The percentage of patients with a positive margin out of the participants

  7 days

Study Arms (1)

Efficacy of Lidocaine mucilage-ICG

EXPERIMENTAL

Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation

Drug: Lidocaine mucilage-ICG

Interventions

Lidocaine mucilage-ICG DRUG

Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Efficacy of Lidocaine mucilage-ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shantou Central Hospital: lead

Study Sites (1)

Shantou Central Hospital

Shantou, Guangdong, 515300, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Si-Qi Qiu, Dr.

  Shantou Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mian-Han Zhuang

CONTACT

008613750445342; jgbst@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: August 20, 2020
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2024
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)