Department of Surgery, Bundang CHA Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi, Republic of Korea.
Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.
BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.
Increasing rates of breast cancer screening have been associated with an increasing frequency of non-palpable breast lesions detection. Preoperative breast lesion localization is essential for optimizing excision accuracy. This study aimed to evaluate the efficacy and safety of indocyanine green (ICG) hyaluronic acid injection as a novel mixture for localization.
We performed a prospective clinical trial with female patients who underwent surgery for non-palpable breast lesions. All patients were sequentially assigned to the control group (localization with activated charcoal), Test Group 1 (ICG-hyaluronic acid mixture 0.1 mL), or Test Group 2 (ICG-hyaluronic acid mixture 0.2 mL) by 1:1:1 ratio.
A total of 44 patients were eligible for this study (Control Group = 14, Test Group 1 = 15, Test Group 2 = 15 patients). Fibroadenoma (n = 17, 38.6%) accounted for the largest proportion of diagnoses, and five patients (11.4%) were diagnosed with malignancies. There were no statistically significant differences in baseline characteristics among the three groups. The marking rate was over 86% in all groups, with no significant intergroup differences. Skin pigmentation was only observed in the control group. The mean accuracy of resection (the greatest diameter of the excised specimen divided by the greatest diameter of the preoperative lesion as observed using ultrasonography, with values closer to 1 reflecting a higher accuracy) was 3.7 in the control group, 2.2 in Test Group 1, and 2.1 in Test Group 2 (p = 0.037 between Controls and Test Group 1, p = 0.744 between Test Group 1 and Test Group 2, and p = 0.026 between Controls and Test Group 2).
ICG-hyaluronic acid injection is a novel method that was shown to accurately localize non-palpable breast lesions and was associated with no skin pigmentation. Further research is required to apply this method to malignant breast lesions. Trial registration "A Multicenter Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark™ Inj. (Conc. for Fluorescence) Localization in Patients with Non-palpable Breast Lesions" was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259 ).
乳腺癌筛查率的增加与非可触及性乳腺病变检测频率的增加有关。术前乳腺病变定位对于优化切除准确性至关重要。本研究旨在评估吲哚菁绿（ICG）透明质酸注射作为一种新型混合物进行定位的效果和安全性。
我们对接受非可触及性乳腺病变手术的女性患者进行了一项前瞻性临床试验。所有患者均按 1:1:1 的比例顺序分为对照组（用活性炭定位）、试验组 1（ICG-透明质酸混合物 0.1mL）和试验组 2（ICG-透明质酸混合物 0.2mL）。
共有 44 名患者符合本研究条件（对照组=14 例，试验组 1=15 例，试验组 2=15 例）。纤维腺瘤（n=17，38.6%）占诊断的最大比例，5 例（11.4%）被诊断为恶性肿瘤。三组患者的基线特征无统计学差异。所有组的标记率均超过 86%，组间无显著差异。仅在对照组观察到皮肤色素沉着。切除的准确性平均值（切除标本的最大直径除以术前超声观察到的病变最大直径，接近 1 表示准确性越高）在对照组为 3.7，试验组 1 为 2.2，试验组 2 为 2.1（对照组与试验组 1 之间 p=0.037，试验组 1 与试验组 2 之间 p=0.744，对照组与试验组 2 之间 p=0.026）。
ICG-透明质酸注射是一种新的方法，能够准确定位非可触及性乳腺病变，且无皮肤色素沉着。需要进一步研究将该方法应用于恶性乳腺病变。试验注册“多中心、开放标签、平行、二期临床试验，以评估 LuminoMark™ Inj.（荧光浓缩物）在非可触及性乳腺病变患者中的疗效和安全性”作为一项试验进行了前瞻性注册（ClinicalTrials.gov 标识符：NCT03743259，注册日期：2018 年 5 月 29 日，https://clinicaltrials.gov/ct2/show/NCT03743259）。
