Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery

Официальное название

A Prospective Study on the Accuracy of Indocyanine Green Fluorescence Imaging for the Visualization of Residual Lesions in the Tumor Cavity During Surgery for Giant Cell Tumor of Bone

Обзор

This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing residual lesions of Giant Cell Tumor of Bone (GCTB) in the tumor cavity during surgery. Patients diagnosed with GCTB will receive an intravenous injection of ICG prior to the operation to label tumor tissues. During the procedure, surgeons will use a near-infrared fluorescence imaging system to visualize the tumor cavity and identify potential residual lesions after standard curettage. The study aims to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICG fluorescence imaging by comparing the intraoperative fluorescence findings with the final pathological results of the validation samples.

Подробное описание

Giant Cell Tumor of Bone (GCTB) poses a significant surgical challenge due to the difficulty in detecting microscopic residual tumor tissues in the bone cavity, which contributes to a high local recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing GCTB lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg/kg) 1-6 hours before surgery. Following standard tumor curettage under white light, the bone cavity will be systematically explored using a near-infrared fluorescence imaging system to visualize potential residual tumor tissues. The surgeon will obtain validation samples from fluorescence-positive areas, fluorescence-negative background tissues, and post-treatment beds for blinded pathological assessment. The study will quantify the diagnostic performance of ICG imaging by calculating sensitivity, specificity, positive predictive value, and negative predictive value based on the pathological gold standard, alongside secondary analyses of tumor-to-background ratios and microscopic tumor boundary concordance.

Вмешательства

• Препарат Indocyanine Green
  Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-6 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration of the bone cavity. The intervention involves a "verify first, treat later" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary curettage of residual fluorescent lesions that were missed during stand

Первичные конечные точки

• Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV) [Срок оценки: From the time of surgery until the final pathology report is available, assessed up to 1 week post-operatively.]

Вторичные конечные точки (2)

• Tumor-to-Background Ratio (TBR) [Срок оценки: Intraoperative]
• Incidence of ICG-Related Adverse Events [Срок оценки: From the time of ICG injection through 24 hours post-surgery]

Критерии участия

Критерии включения

• Diagnosed with Giant Cell Tumor of Bone(GCTB), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection.
• Capable of understanding the study and voluntarily signing the written informed consent form.

Критерии исключения

• Known severe history of allergy to Indocyanine Green (ICG) or iodine.
• Severe liver dysfunction.
• Women who are pregnant or lactating.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Shanghai Sixth People's Hospital — Шанхай

Публикации

• Nicoli F, Saleh DB, Baljer B, Chan CD, Beckingsale T, Ghosh KM, Ragbir M, Rankin KS. Intraoperative Near-infrared Fluorescence (NIR) Imaging With Indocyanine Green (ICG) Can Identify Bone and Soft Tissue Sarcomas Which May Provide Guidance for Oncological Resection. Ann Surg. 2021 Feb 1;273(2):e63-e68. doi: 10.1097/SLA.0000000000003857. PMID 32224746
• Wang H, Ji T, Qu H, Yan T, Li D, Yang R, Tang X, Guo W. Indocyanine green fluorescence imaging may detect tumour residuals during surgery for bone and soft-tissue tumours. Bone Joint J. 2023 May 1;105-B(5):551-558. doi: 10.1302/0301-620X.105B5.BJJ-2022-0803.R1. PMID 37121591
• Huang H, He S, Wei R, Zhu X, Deng Z, Wang Y, Guo L, Lei J, Cai L, Xie Y. Near-infrared (NIR) imaging with indocyanine green (ICG) may assist in intraoperative decision making and improving surgical margin in bone and soft tissue tumor surgery. J Surg Oncol. 2023 Sep;128(4):612-627. doi: 10.1002/jso.27306. Epub 2023 May 13. PMID 37178368
• Vinegoni C, Botnaru I, Aikawa E, Calfon MA, Iwamoto Y, Folco EJ, Ntziachristos V, Weissleder R, Libby P, Jaffer FA. Indocyanine green enables near-infrared fluorescence imaging of lipid-rich, inflamed atherosclerotic plaques. Sci Transl Med. 2011 May 25;3(84):84ra45. doi: 10.1126/scitranslmed.3001577. PMID 21613624
• Newton AD, Predina JD, Shin MH, Frenzel-Sulyok LG, Vollmer CM, Drebin JA, Singhal S, Lee MK 4th. Intraoperative Near-infrared Imaging Can Identify Neoplasms and Aid in Real-time Margin Assessment During Pancreatic Resection. Ann Surg. 2019 Jul;270(1):12-20. doi: 10.1097/SLA.0000000000003201. PMID 31188797
• Dip F, Boni L, Bouvet M, Carus T, Diana M, Falco J, Gurtner GC, Ishizawa T, Kokudo N, Lo Menzo E, Low PS, Masia J, Muehrcke D, Papay FA, Pulitano C, Schneider-Koraith S, Sherwinter D, Spinoglio G, Stassen L, Urano Y, Vahrmeijer A, Vibert E, Warram J, Wexner SD, White K, Rosenthal RJ. Consensus Conference Statement on the General Use of Near-infrared Fluorescence Imaging and Indocyanine Green Guide PMID 33214476
• Machak GN, Snetkov AI. The impact of curettage technique on local control in giant cell tumour of bone. Int Orthop. 2021 Mar;45(3):779-789. doi: 10.1007/s00264-020-04860-y. Epub 2020 Oct 22. PMID 33094400
• Aoude A, Nikomarov D, Perera JR, Ibe IK, Griffin AM, Tsoi KM, Ferguson PC, Wunder JS. Giant cell tumour of bone. Bone Joint J. 2023 May 1;105-B(5):559-567. doi: 10.1302/0301-620X.105B5.BJJ-2022-1231.R1. PMID 37121582

Идентификаторы

NCT: NCT07315828 · 2025-146 · 2025-146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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