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HOME > J Surg Innov Educ > Volume 1(2); 2024 > Article
How I Do It
 LuminoMark: An Alternative for Localization
Ee Jin Kimorcid, Tae Kyung Yooorcid, Jisun Kimorcid, Il Yong Chungorcid, Beom Seok Koorcid, Hee Jeong Kimorcid, Jong Won Leeorcid, Byung Ho Sonorcid, Sae Byul Leeorcid
Journal of Surgical Innovation and Education 2024;1(2):46-48.
DOI: https://doi.org/10.69474/jsie.2024.00178
Published online: December 13, 2024

Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

Corresponding author: Sae Byul Lee, MD, PhD Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea Tel: +82-2-3010-1729, Fax: +82-2-474-9027, E-mail: 'newstar153@hanmail.net'
• Received: October 31, 2024   • Revised: November 20, 2024   • Accepted: November 25, 2024

© 2024 Korean Surgical Skill Study Group

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Breast cancer is the most common cancer among women in Korea. Given the increased preference for breast-conserving surgery (BCS), preoperative localization is crucial, especially for non-palpable lesions, to ensure clear resection margins. Traditional methods such as wire-guided localization have limitations, including patient discomfort and wire migration. Recently, LuminoMark, an indocyanine green–macroaggregated albumin–hyaluronic acid mixture, has emerged as a promising alternative with potential benefits over existing techniques. We present a case of a 67-year-old female with a non-palpable Breast Imaging-Reporting and Data System 5 breast lesion. Preoperative localization was performed using LuminoMark, with accurate placement verified by a Lumino-imager. The lesion was successfully excised, and the absence of residual fluorescence confirmed complete resection. LuminoMark provided effective lesion localization without skin pigmentation, reducing the risk of misdiagnosis during follow-up. The procedure demonstrated a short learning curve, similar to that of charcoal localization. However, the need for a costly near-infrared fluorescence detector and the lack of long-term follow-up data are current limitations. Despite minor drawbacks, LuminoMark offers advantages over traditional localization methods, including improved aesthetics and reduced complications. This case demonstrates its feasibility as a next-generation localization technique for BCS, emphasizing the importance of an accurate injection technique to ensure adequate dispersion and complete tumor resection. Further studies are warranted to validate its long-term efficacy.
  • Keywords: Localization, Breast, Indocyanine green
In Korea, breast cancer is the leading cancer in women, with a total of 28,851 new cases, accounting for 22.4% of all female cancer patients [1]. With the improvement in the 5-year relative survival rate (93.6%), an increasing number of patients and surgeons prefer breast-conserving surgery (BCS) to total mastectomy (68.6%) [2]. Since the resection margin (RM) is important for preventing local recurrences in BCS, preoperative localization serves as a safeguard for ensuring a clear RM, especially in the case of non-palpable breast lesions [3]. The concept of localizing breast lesions was first described by Dodd et al. [2] in 1966, using fluoroscopic guided wire localization. In 1976, Frank et al. [4] modified this technique adding a hook tip. Today, wire-guided localization remains the most widely used method for localization of breast lesions. Localization wires vary in length from 3 to 15 cm and are preloaded in a 16 to 21 G needle introducer. The wire may include a hook, barb or pigtail to anchor it in place [5]. In recent years, however, many wire-free localization techniques have been introduced, utilizing radioactive methods or non-radioactive methods, such as carbon localization, SAVI SCOUT, MagSeed, and LOCalizer.
In Korea, possible choice among the options, carbon (Charcoal suspension) localization, first reported by Svane [6] in 1983, is often used as a cost-effective alternative. Charcoal suspension stains the tissue black, does not diffuse into the surrounding tissue, and allows the surgeon to localize the lesion even days or weeks later [6]. However, there have also been reports that carbon suspension can cause foreign-body giant-cell reactions, which may mimic malignancy on mammography and potentially lead to misdiagnosis during the follow-up period [7]. In addition, Rose et al. [8] reported a higher rate of close or involved margins when using carbon localization compared to wire-guided localization.
In addition, wire-guided localization, require percutaneous placement of a wire within the breast, with distal portion of the wire remaining outside the breast. Therefore, this procedure must be performed on the day of surgery or, at the latest, the day prior. In addition to this inconvenience, the procedure can cause pain for patients, and in some cases, the wire may become misplaced into the muscle, particularly in patients with scant breast tissue. This displacement can lead to bleeding and significant pain.
Similar concept with carbon localization, LuminoMark was approved by the Drug Apporval System in Korea in May 2023. LuminoMark is an indocyanine green–macroaggregated albumin–hyaluronic acid mixture developed by Hanlim Pharm. Co., Ltd., Seoul, Republic of Korea. A parallel phase 2 and 3 multicenter clinical trial showed that LuminoMark was superior to charcoal regarding skin pigmentation and improving resection accuracy [9]. This paper aims to demonstrate the feasibility of LuminoMark as a new alternative for localization, as subsequently presented through the video.
A 67-year-old female patient was referred to our institution for surgical management following the detection of a Breast Imaging-Reporting and Data System category 5 breast lesion during a routine mammogram (MMG) and ultrasound at a local clinic. A core needle biopsy confirmed invasive ductal carcinoma. The patient had been undergoing hormone replacement therapy for menopausal symptoms for the past 10 years and had a family history of breast cancer in her older sister. Her body mass index was 32.62 kg/m2. On physical examination, the mass was non-palpable, and there was no axillary lymphadenopathy. MMG at our institution revealed a 2.7 cm irregular isodense mass in the right upper inner quadrant. Ultrasound identified an irregular hypoechoic lesion measuring 2.2×1.9×1.3 cm at the 1 o’clock position, 8 cm from the nipple, with no additional remarkable findings. This study was approved by the Institutional Review Board (IRB) of Asan Medical Center (IRB No: 2018-0079).
Surgical procedures
Following anesthesia in the usual manner, the lesion location was identified using ultrasound. As shown in the imaging, 0.2 mL of the prepared LuminoMark solution was injected at the tumor surface for localization. Accurate localization of the lesion was verified using the Lumino-imager, before and after the incision was made. Following the incision, marking the tumor boundaries with a needle at each end for convenience. Upon completing the resection, the Lumino-imager was used to confirm that both the excised lesion and the tumor bed were free of residual fluorescence, indicating complete removal.
There were several options for localization, and it’s important to carefully weigh the pros and cons. The current gold standard is wire-guided localization, but it has weaknesses regarding patient’s pain, wire migration, time limitation [10]. Rose et al. [8] demonstrated that the learning curve for carbon localization is relatively short, taking less than 2 weeks. Similarly, as LuminoMark utilizes the same principle as charcoal it also has a relatively short learning curve. Furthermore, it offers more advantages than carbon localization in terms of aesthetics, being free from skin pigmentation and reducing the risk of misdiagnosis during follow-up mammography, as mentioned earlier regarding foreign-body giant-cell reactions [7].
However, some limitations remain. Although indocyanine green is safe and widely used in various clinical fields, LuminoMark lacks long-term follow-up data, necessitating further research. Additionally, the use of LuminoMark requires a specialized and costly detector for near-infrared fluorescence imaging, which utilizes indocyanine green to emit fluorescence for visualization. Despite these minor drawbacks, the benefits of LuminoMark could outweigh these challenges, making it a feasible option for next-generation localization.
Upon these advantages, we aimed to achieve a more precise and accurate localization using LuminoMark. Since achieving a clear margin is a critical part in BCS, a precise technique is required when injecting LuminoMark. Because many tumors are too solid to inject the solution, pulling the needle back slightly can help. Nevertheless, the fluorescence may still be clearly visible on the skin surface. It is also essential to inject very slowly to allow sufficient time for the solution to disperse.
Video.
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  • 2. Dodd GD, Fry K, Delany W. Preoperative localization of occult carcinoma in the breast. In: Nealon TF, editor. Management of the patient with cancer. Saunders Co; 1966. p. 183.
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  • 4. Frank HA, Hall FM, Steer ML. Preoperative localization of nonpalpable breast lesions demonstrated by mammography. N Engl J Med. 1976;295:259-260.ArticlePubMed
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  • 6. Svane G. A stereotaxic technique for preoperative marking of non-palpable breast lesions. Acta Radiol Diagn (Stockh). 1983;24:145-151.ArticlePubMedPDF
  • 7. Ruiz-Delgado ML, López-Ruiz JA, Sáiz-López A. Abnormal mammography and sonography associated with foreign-body giant-cell reaction after stereotactic vacuum-assisted breast biopsy with carbon marking. Acta Radiol. 2008;49:1112-1118.ArticlePubMedPDF
  • 8. Rose A, Collins JP, Neerhut P, Bishop CV, Mann GB. Carbon localisation of impalpable breast lesions. Breast. 2003;12:264-269.ArticlePubMed
  • 9. Bang YJ, Choi HJ, Kim I, Lee MH, Lee S, Shin HJ, et al. 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. Front Oncol. 2023;13:1039670.ArticlePubMedPMC
  • 10. Banys-Paluchowski M, Kühn T, Masannat Y, Rubio I, de Boniface J, Ditsch N, et al. Localization techniques for non-palpable breast lesions: current status, knowledge gaps, and rationale for the MELODY study (EUBREAST-4/iBRA-NET, NCT 05559411). Cancers (Basel). 2023;15:1173.ArticlePubMedPMC

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        LuminoMark: An Alternative for Localization
        J Surg Innov Educ. 2024;1(2):46-48.   Published online December 13, 2024
        DOI: https://doi.org/10.69474/jsie.2024.00178
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