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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Efficacy of Lidocaine mucilage-ICG

Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation

Group Type EXPERIMENTAL

Lidocaine mucilage-ICG

Intervention Type DRUG

Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Interventions

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Lidocaine mucilage-ICG

Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No