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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-146 | Other Identifier | Ethics Committee of Shanghai Sixth People's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG Fluorescence Imaging Group | Experimental | All enrolled participants receive ICG fluorescence-guided surgery. Following standard tumor curettage, the bone cavity is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for blinded pathological assessment, and performing supplementary curettage of confirmed suspicious lesions to achieve potentially cleaner surgical margins. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | 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 standard white-light surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV) | The diagnostic performance of ICG fluorescence imaging in detecting GCTB lesions will be evaluated by comparing the intraoperative fluorescence status (Positive/Negative) with the final histopathological diagnosis (Tumor/Non-tumor) of the resected specimens. The unit of analysis is the individual specimen. The following metrics will be calculated: Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV). | From the time of surgery until the final pathology report is available, assessed up to 1 week post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor-to-Background Ratio (TBR) | TBR is a quantitative measure of fluorescence intensity. It will be calculated by dividing the mean fluorescence intensity of the tumor region by the mean fluorescence intensity of the adjacent normal background tissue using image analysis software. | Intraoperative |
| Incidence of ICG-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingcheng Yang, Prof. | Contact | +86 21 6431 9181 | tjyqc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32224746 | Result | 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. | |
| 37121591 |
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| ID | Term |
|---|---|
| D018212 | Giant Cell Tumor of Bone |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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This is a prospective, single-center, single-arm study.
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The number of participants experiencing adverse events related to ICG administration (e.g., allergic reactions, anaphylactic shock) will be monitored and recorded. |
| From the time of ICG injection through 24 hours post-surgery |
| 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. |
| 37178368 | Result | 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. |
| 21613624 | Result | 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. |
| 31188797 | Result | 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. |
| 33214476 | Result | 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 Guided Surgery: Results of a Modified Delphi Study. Ann Surg. 2022 Apr 1;275(4):685-691. doi: 10.1097/SLA.0000000000004412. |
| 33094400 | Result | 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. |
| 37121582 | Result | 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. |
| 33754215 | Result | Basu Mallick A, Chawla SP. Giant Cell Tumor of Bone: An Update. Curr Oncol Rep. 2021 Mar 22;23(5):51. doi: 10.1007/s11912-021-01047-5. |
| 17013643 | Result | Werner M. Giant cell tumour of bone: morphological, biological and histogenetical aspects. Int Orthop. 2006 Dec;30(6):484-9. doi: 10.1007/s00264-006-0215-7. Epub 2006 Sep 30. |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |