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The efficacy and safety of an indocyanine green-hyaluronic acid mixture (LuminoMark™) for localization in patients with non-palpable breast lesions: A multicenter, randomized, open-label, parallel phase 3 clinical trial

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Author(s)
Yoon Ju BangHee Jun ChoiIsaac KimMoo-Hyun LeeSeeyoun LeeHyuk Jai ShinSeok Jin NamJeong Eon LeeByung-Joo ChaeSe Kyung LeeJai Min RyuSeok Won Kim
Keimyung Author(s)
Lee, Moo Hyun
Department
Dept. of Surgery (외과학)
Journal Title
Front Oncol
Issued Date
2023
Volume
13
Keyword
excisionindocyanine greenindocyanine green (ICG)localizationnon-palpable
Abstract
Purpose:
The incidence of early tumor detection is increasing due to popularization of breast cancer screening and the development of imaging techniques. Thus, suitable preoperative localization is required for proper diagnosis and treatment of non-palpable breast lesions. The purpose of this study was to evaluate the efficacy and safety of indocyanine green (ICG)-hyaluronic acid (HA) mixture for lesion localization compared to activated charcoal.

Methods:
This was a multicenter, randomized, open-label, parallel phase 3 clinical trial performed at four centers in Korea. Female patients scheduled for surgery to remove non-palpable breast lesions were enrolled. One hundred and nine patients were randomly assigned to a control group (activated charcoal: 0.3. - 1 mL) or a study group (ICG-HA mixture, 0.2 mL) for the localization of a breast lesion. The primary endpoint was the accuracy of resection. Secondary endpoints included the technical success rate, histopathological accuracy, skin pigmentation rate, and adverse event rate.

Results:
A total of 104 patients were eligible for per-protocol analysis (control group, n = 51; study group, n = 53). The accuracy of resection in the study group was not inferior to that of the control group (90.57% vs. 98.04%, 95% confidence interval (CI): -2.31 - 18.91, p = 0.21). There was no statistically significant difference in technical success rate between the two groups (marking on breast skin: p = 0.11, marking on the excised specimen: p = 0.12). However, there were statistically significant differences in histopathological accuracy (0.26 ± 0.13 vs. 0.33 ± 0.17, p = 0.01) and skin pigmentation rate (0.00% vs. 30.77%, p< 0.01). Adverse events were not reported in either group.

Conclusions:
When localization was performed using ICG-HA, the accuracy of resection was not inferior to that of activated charcoal. However, skin pigmentation rate was significantly lower. In conclusion, ICG-HA is effective and safe for localizing of non-palpable breast lesions.
Keimyung Author(s)(Kor)
이무현
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
2234-943X
Source
https://www.frontiersin.org/articles/10.3389/fonc.2023.1039670/full
DOI
10.3389/fonc.2023.1039670
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44842
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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