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

NCT07315841 | Recruiting Phase 4 DMC

• 1 other identifier: 2025-147
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing Tenosynovial Giant Cell Tumor (TGCT) lesions during surgery. Patients diagnosed with TGCT 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 and potential residual lesions in the surgical bed. 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 resected tissues.

Conditions

Tenosynovial Giant Cell Tumor

Keywords

Indocyanine Green; Fluorescence Imaging; Near-Infrared Imaging; Tenosynovial Giant Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV)

  The diagnostic performance of ICG fluorescence imaging in detecting TGCT 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.

Secondary Outcomes (2)

• Tumor-to-Background Ratio (TBR)

  Intraoperative

• Incidence of ICG-Related Adverse Events

  From the time of ICG injection through 24 hours post-surgery

Study Arms (1)

ICG Fluorescence Imaging Group

EXPERIMENTAL

All enrolled participants receive ICG fluorescence-guided surgery. Following standard tumor resection, the surgical bed is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for pathology, and performing supplementary resection of confirmed suspicious lesions to achieve potentially cleaner surgical margins.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-3 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration. The intervention involves a "verify first, treat later" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary resection of residual fluorescent lesions that were missed during standard white-light surgery.

ICG Fluorescence Imaging Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Tenosynovial Giant Cell Tumor (TGCT), including both Localized-type (L-TGCT) and Diffuse-type (D-TGCT), 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

Related Publications (10)

• 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 RESULT

• 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 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.

  PMID: 37178368 RESULT

• He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.

  PMID: 29290809 RESULT

• He K, Li P, Zhang Z, Liu J, Liu P, Gong S, Chi C, Liu P, Chen C, Tian J. Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2929-2937. doi: 10.1007/s00259-022-05686-z. Epub 2022 Mar 1.

  PMID: 35230489 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.

  PMID: 21613624 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.

  PMID: 31188797 RESULT

• Gouin F, Noailles T. Localized and diffuse forms of tenosynovial giant cell tumor (formerly giant cell tumor of the tendon sheath and pigmented villonodular synovitis). Orthop Traumatol Surg Res. 2017 Feb;103(1S):S91-S97. doi: 10.1016/j.otsr.2016.11.002. Epub 2017 Jan 2.

  PMID: 28057477 RESULT

• Stacchiotti S, Durr HR, Schaefer IM, Woertler K, Haas R, Trama A, Caraceni A, Bajpai J, Baldi GG, Bernthal N, Blay JY, Boye K, Broto JM, Chen WT, Dei Tos PA, Desai J, Emhofer S, Eriksson M, Gronchi A, Gelderblom H, Hardes J, Hartmann W, Healey J, Italiano A, Jones RL, Kawai A, Leithner A, Loong H, Mascard E, Morosi C, Otten N, Palmerini E, Patel SR, Reichardt P, Rubin B, Rutkowski P, Sangalli C, Schuster K, Seddon BM, Shkodra M, Staals EL, Tap W, van de Rijn M, van Langevelde K, Vanhoenacker FMM, Wagner A, Wiltink L, Stern S, Van de Sande VM, Bauer S. Best clinical management of tenosynovial giant cell tumour (TGCT): A consensus paper from the community of experts. Cancer Treat Rev. 2023 Jan;112:102491. doi: 10.1016/j.ctrv.2022.102491. Epub 2022 Dec 6.

  PMID: 36502615 RESULT

• Palmerini E, Staals EL. Treatment updates on tenosynovial giant cell tumor. Curr Opin Oncol. 2022 Jul 1;34(4):322-327. doi: 10.1097/CCO.0000000000000853.

  PMID: 35837703 RESULT

MeSH Terms

Conditions

Giant Cell Tumor of Tendon Sheath

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qingcheng Yang, Prof.

CONTACT

+86 21 6431 9181; tjyqc@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Orthopaedic Surgeon & Director

Model Details: This is a prospective, single-center, single-arm study.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 2, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)