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NCT Number: NCT07315841

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

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.

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Key information

Conditions

Tenosynovial Giant Cell Tumor Giant Cell Tumor of Tendon Sheath Giant Cell Tumors Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Synovitis Tendinopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Sixth People's Hospital

Shanghai, China

Location status: Recruiting

Location contact

Qingcheng Yang, Doctor

CONTACT

[email protected]

021-64369181

About this study

Tenosynovial Giant Cell Tumor (TGCT), especially the diffuse type, poses a significant surgical challenge due to its infiltrative growth and high recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing TGCT lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg/kg) 1-3 hours before surgery. Following standard tumor resection under white light, the surgical bed will be systematically explored using a near-infrared fluorescence imaging system to visualize potential tumor tissues. The surgeon will obtain validation samples from both fluorescence-positive areas and fluorescence-negative background tissues 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From the time of surgery until the final pathology report is available, assessed up to 1 week post-operatively.

    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).

Secondary outcomes

  1. Tumor-to-Background Ratio (TBR)

    Time frame: Intraoperative

    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. Values will be compared between Diffuse-type TGCT (D-TGCT) and Localized-type TGCT (L-TGCT) cohorts.

  2. Incidence of ICG-Related Adverse Events

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

    The number of participants experiencing adverse events related to ICG administration (e.g., allergic reactions, anaphylactic shock) will be monitored and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingcheng Yang, Prof.

CONTACT

[email protected]

+86 21 6431 9181

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

A Prospective Study Evaluating the Accuracy of Indocyanine Green Fluorescence Imaging in Detecting Lesions During Tenosynovial Giant Cell Tumor Surgery

Acronym: ICG-TGCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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